Regulatory Manager Resume Samples

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LH
L Homenick
Lorine
Homenick
11279 McGlynn Harbor
Dallas
TX
+1 (555) 498 7020
11279 McGlynn Harbor
Dallas
TX
Phone
p +1 (555) 498 7020
Experience Experience
Los Angeles, CA
Regulatory Manager
Los Angeles, CA
Hegmann-Lindgren
Los Angeles, CA
Regulatory Manager
  • Manage and provide feedback and support to contract resources providing regulatory intelligence to Shell
  • Provide and manage regulatory and scientific input to confectionery product and process development
  • Plan and execute regulatory activities in AME and find innovative registration approaches within the legal regulatory framework
  • Working with clients to develop or review their ORSA
  • Providing advice and assurance on matters of capital, risk management and governance
  • Plan and execute regulatory activities in Zambia and find innovative registration approaches within the legal regulatory framework
  • Provide country specific regulatory expertise to global product development teams
Detroit, MI
Quality / Regulatory Manager
Detroit, MI
Crooks, Abernathy and Grimes
Detroit, MI
Quality / Regulatory Manager
  • Maintain ISO certification, perform audits and work with auditors to improve processes
  • Support the Management of Daily Improvement (MDI)
  • Establishes (through quality monitoring), performs follow-up and ensure closure of corrective and or preventive actions
  • Performs all scheduled quality monitoring activities (including internal audits, management evaluations, inspections, supplier audits, etc.,)
  • Provide management with an independent assessment of corrective and preventive actions, their implementation and completion
  • Be the designated SMS Manager
  • Implements, monitors and coordinates improvements to the Quality and Regulatory System
present
Boston, MA
Compliance & Regulatory Manager
Boston, MA
Orn, Reichert and Abshire
present
Boston, MA
Compliance & Regulatory Manager
present
  • Provide staff members with leadership, guidance, mentoring, coaching, and feedback against performance and development objectives
  • Contribute to process improvement initiatives and represent QA on project teams, management meetings, and other internal forums
  • Developing a compliance framework
  • Active involvement in developing new business opportunities and working closely with other departments within the firm to do so
  • Provide department quality metrics and tracker information to Senior Management monthly
  • Developing compliance policies and procedures
  • Manage a QA auditor team responsible for lab data review, lab investigations review, methods/protocol approvals and COA issuance
Education Education
Bachelor’s Degree in Food Science
Bachelor’s Degree in Food Science
University of Arizona
Bachelor’s Degree in Food Science
Skills Skills
  • Ability to apply detailed knowledge of organizational procedures to make independent decisions and serve as a credible resource for a senior management team
  • Great communication, organization and attention-to-detail skills
  • Strong interpersonal skills and ability to interact positively with all functions
  • Good understanding of product supply chains and organizations involved globally and being able to effectively contribute within these chains and organizations
  • Demonstrates strong teamwork skills and is able to lead, collaborate and work effectively in teams across different businesses, functions and geographies
  • Ability to adapt regulatory knowledge/experience to the Agilent environment and develop solutions that are appropriate for Agilent
  • Basic knowledge of hazard communication regulations in EAME region
  • Excellent knowledge of MS Office (Word, Excel and Power Point)
  • Strong written and verbal communication; ability to present to various audiences’ levels
  • Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance
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15 Regulatory Manager resume templates

1

Regulatory Manager Resume Examples & Samples

  • Advise clients with deep technical insights and build credibility based on an understanding of their challenges related to technical matters. Assist in preparing risk assessments and annual plans for financial services clients. Provide high quality, professional day-to-day execution of engagements and projects in line with firm risk management practices for the financial services practice
  • Develop ideas to expand EY’s current offerings and initiate discussions with clients. Identify and communicate findings to senior management and client personnel
  • Supervise project work prepared by more junior professionals, providing feedback and guidance on quality outputs
  • Understand firm service offerings and mentor associates, interns, and new hires
  • Regulatory experience at the FSA/ FCA, a FTSE 100 Financial Services organisation, one of the other Top 4 consultancies, or another Advisory firm
  • Knowledge of CASS, governance, conduct risk, new regulatory developments such as MiFID 2 would be beneficial
  • Strong academic background which could include the following: 2:1 degree, CII Exams ( FPC / AFPC), CISI Level 4, Prince 2, CeMAP, CeFA and / or Other Financial Services qualifications
2

Emeia FSO Regulatory Manager Resume Examples & Samples

  • Engagement planning, management, and leading teams in remediation engagements and on-going compliance work
  • Supporting bids and proposals for new client opportunities and grow existing valued relationships
  • Work effectively as a team member sharing responsibility, providing support and updating senior members on progress; and
  • Mentoring staff and conduct performance reviews and contribute to performance feedback for staff
  • Strong academic background, ideally to a degree level or equivalent
  • Knowledge of the UK and European financial regulatory environment (knowledge of the global environment an advantage)
  • Regulatory compliance work experience. Consulting experience and/or a relevant professional qualification would be an advantage
  • Technical knowledge of financial products or regulated activities (e.g. Anti-Money Laundering, Know Your Client, FATCA and Suitability Reviews)
  • A focus on one or more of the following areas: Wholesale Banking, Retail Banking, Wealth, Asset Management and Insurance
  • Enthusiasm to be involved in marketing activity and developing the Managed Services team; and
  • A willingness to travel
3

Business Risk & Regulatory Manager Resume Examples & Samples

  • Administer and manage the risk, regulatory and tax heat map
  • Perform operational error analyses and set up meaningful statistics
  • Review and endorsement of new policies
  • Prepare and lead the IPS CFMP Risk, Regulatory and Tax Committees
  • Represent CFMP in regulatory related working groups, project meetings, etc
  • Partner with various stakeholders to ensure that the business is adequately
  • Bachelor / Master degree, preferably in Law or Business Administration
  • Experience in Banking / Finance within a Risk & Regulatory, Compliance, Audit or comparable department
  • Mature and able to work independently with minimal supervision
  • Fluency in German and English both oral and written
4

Risk & Regulatory Manager Resume Examples & Samples

  • Oversee and provide quality assurance for the Op Risk Events process managed by the Op Risk Analyst
  • Provide support and guidance to the Op Risk Analyst with regard to significant events, escalation to Senior Management and contested issues
  • Review loss calculations to ensure fair treatment of clients
  • Oversee and provide quality assurance for the monthly collation and reporting process conducted by the Compliance Administrator
  • Facilitate the annual ICAAP update including acting as secretary for the ICAAP Working Group
  • Gather and prepare documentation and obtain appropriate sign off of the ICAAP
  • Maintain documentation for internal record keeping and external regulatory review purposes
  • Assist the Senior Risk Manager as necessary including
  • Management information development
  • Preparation of management committee and Board reports
  • Maintenance and development of relevant operational risk policies and procedures
  • Any other duties as deemed appropriate by the Senior Risk Manager
  • Work as a member of the Op Risk Team to ensure linkages between distinct risk management activities (such as RCSA, KRIs and Op Risk events)
  • Manage the Risk & Compliance business continuity plan and strategy
  • Contribute to Committee and Board meeting pack preparation
  • Experience in an Operational Risk
  • Experience in the asset management industry (including wealth management or investment consultants) preferable
  • Completion of a risk or investment management certificate (e.g. IMC) preferable
  • Experience reviewing, facilitating or contributing to internal capital planning including stress testing, reverse stress testing and orderly wind down
  • Experience with management reporting and escalation of issues
  • Experience with development and analysis of Key Risk Indicators
  • Familiarity with Risk Control Self-Assessment and other business risk assessment processes
  • Ability to work independently, research and investigate issues as needed, and present results in a timely and professional manner
  • Strong time management and work prioritisation skills
  • Team player who demonstrates flexibility and desire to share information and support junior members of staff in their development
5

Regional Management Team-risk & Regulatory Manager Resume Examples & Samples

  • Review and analyze client portfolios from a risk and suitability perspective, including account activity, transaction history and client correspondence
  • Proactively identify inconsistencies between client account activity as compared to internal investment policy guidelines, the client’s stated investment objectives, risk tolerances and portfolio goals, and work with PWM Teams to address
  • Present at bi-weekly Risk Committee meetings on accounts with the highest levels of risk. Collaborate with Committee Members and PWM Teams to develop and implement risk mitigating recommendations by creating customized risk reports for client presentation purposes and establishing / imposing risk thresholds when appropriate
  • Keep PWM Teams apprised of regulatory changes and their potential impact to the PWM business while also educating PWM personnel on the internal policies and controls designed to comply with such changes
  • Collaborate with PWM teams, Product Teams and the Strats Team to identify accounts posing excessive economic risk to the client or the firm. Advise Private Wealth Advisors on how to communicate and address potential issues with clients and, where necessary, set risk thresholds
  • Ensure that client profile changes, portfolio reviews and noteworthy account activities are documented appropriately through investment and relationship notes
  • Assess potential risks associated with trades/account activity requiring additional approvals due to risk thresholds/controls being potentially exceeded
  • Coordinate regular reviews of account types with heightened supervisory requirements
  • Manage and participate in various regional supervisory reviews of PWM accounts including the Annual Account Review
  • Analyze metrics to identify operational and reputational risks while escalating findings to relevant stakeholders involved in related processes
  • Work with Strats Team to develop specific risk analytics / reporting to be used internally and/or externally with clients
  • Report regularly to the US PWM COO and PWM Region Heads in each coverage office, keeping them apprised of key client and business risks and the steps being taken to mitigate them
  • Minimum of 5 years of experience in a financial organization, preferably in the private wealth high net worth area or a compliance/legal function
  • Experience in risk analysis and management and/or regulatory reform strongly preferred
  • Working knowledge of products typically held in private wealth management accounts including structured products and derivatives
  • Excellent interpersonal, leadership and communication skills and a desire to work in a team-oriented environment
  • Retain good judgment and discretion, particularly when placed in demanding situations
  • Outstanding analytical skills; ability to work with detailed financial or other data and understand and communicate commercial implications
  • Self-starter who takes ownership and can lead/manage projects independently
  • Series 7, 9 and 10 required (must be obtained within six months of employment)
6

Senior Regulatory Manager Resume Examples & Samples

  • 6 years of relevant accounting experience
  • Strong regulatory reporting knowledge, including experience with FR Y9C, Call Report, FFIEC 009, etc
  • Strong data aggregation skills
  • Excellent Microsoft Excel knowledge
  • Strong understanding of US GAAP
  • Experience in databases and systems
  • Peoplesoft / Hyperion experience
7

Human Resources Regulatory Manager Resume Examples & Samples

  • Responsible for all HR regulatory matters for the APAC region – from monitoring and understanding regulatory requirements (in partnership with the relevant location and external subject matter experts) to translating into deliverable solutions for the firm
  • Subject Matter Expert with the ability to understand the impact of regulatory and other external and internal changes on the Firm’s business
  • Maintain a detailed understanding of the regulatory restrictions placed on compensation structures and people practices and the impact on the Firm’s business, developing proposals to manage that impact and updating senior management
  • Collaborating with the rest of the Compensation & Benefits team and APAC HR team, as well as key Global stakeholders, to produce integrated solutions
  • Ensuring HR Business Partners (including HR Country Heads) are fully informed and onboard with the regulatory landscape
  • Tracking the progress of new HR-related regulations through relevant approval processes (especially those related to compensation and performance management aspects of HR)
  • Reviewing HR regulatory guidelines, etc. to determine impacts on the Firm’s business and employees – this will involve working closely with functions across the Firm in APAC and globally (e.g., Legal, Compliance, local HR)
  • Delivering updates and presentations for senior management on issues and proposed solutions
  • Ensuring compliant implementation of new regulations (including incorporating local requirements within the global framework)
  • Producing responses to regulators throughout the APAC region as well ad-hoc queries on specific issues
  • Overseeing the Firm’s statutory regulatory and public compensation disclosures for APAC
  • Excellent interpersonal and communications skills; it will be essential to quickly build credibility with the key internal stakeholders
  • Excellent and proven quantitative analytical skills
8

Regulatory Manager Resume Examples & Samples

  • Initiates approval tracking in database
  • When requested by PI, initiates IND application to the FDA
  • Will follow progress of on-line submission. Will remind investigators to sign off on submission approval if not done within a few days. Will promptly initiate response to any stipulations or assist investigators in formulating a response
  • On notice of IRB approval, will notify café database person so that protocol and Informed Consents can be posted on web site and the set up for patient registration can be initiated. Protocol will be also be added to the Protocol Priority List and coordinators will be notified
  • Submits promptly any revisions or amendments and Continuing Reviews to the IRB
  • Gives approved amendments/revisions to database managers to update data management tools and posting on web site
  • Ensures that External Serious Adverse Events are submitted from sponsors
  • At all times, keep Study File updated for source document tracking
  • Submits study to the Central IRB (CIRB) with Spanish version of IC
  • For Continuing Review yearly will submit CIRB approvals to IRB to have date stamped on Informed Consent
  • Submits signed CTSU form to CTSU
9

Human Resources Regulatory Manager Resume Examples & Samples

  • Special focus on providing strategic advice and guidance for our China businesses on compensation and HR regulatory matters
  • Ensuring HR Business Partners (including HR Country Heads) are fully informed and on board with the regulatory landscape
  • Written and spoken Chinese language skills would be beneficial
10

Risk & Regulatory Manager Resume Examples & Samples

  • College degree is requested and 10 years of experience
  • Experience and knowledge of Risk Control Self-Assessment, preferred
  • Issue/Incident Management experience, preferred
  • Ability to communicate effectively to all levels within the firm and externally
  • Proven ability to execute and meet deadlines in a dynamic environment
  • Former control/process testing experience, a plus
  • Audit facilitation/coordination experience, a plus
  • Technical expertise with Microsoft Access, Excel and/or SQL Databases, a plus
11

Financial Services Regulatory Manager Resume Examples & Samples

  • Organising, managing and delivering impact assessment or gap analysis engagements on various regulatory matters (MiFID II, FATCA & CRS)
  • Delivering workshops and training sessions on various regulatory topics (MiFID II, FATCA & CRS)
  • Supporting proactively the sales initiatives in MiFID II, FATCA & CRS and contributing to our substantial growth (support in sales pursuits, point of views, conferences, articles, MiFID II, FATCA & CRS decks, etc.)
  • Helping in the management of our regulatory Advisory practice (internal coordination, coaching of team members, coordination with EMEIA, etc.)
12

Regulatory Manager Resume Examples & Samples

  • At all times, keep Study File updated for source document tracking (sponsor correspondence, revisions, IRB correspondence.)
  • Prepares Regulatory files for sponsor site visit review on request
  • Notifies study coordinators of study accrual closure
  • At study termination, closes study and terminates study at IRB
  • Stores records for 15 years after termination
13

WM Regulatory Manager Resume Examples & Samples

  • Collaborate closely with colleagues from other disciplines (legal, tax, markets, product management, etc.) to ensure solutions are agreed and complete
  • Perform analysis of new requirements and propose and develop feasible solutions
  • Analyze policies and other documents to support the identification and extraction of rules
  • Design, implement and test rules in the rule engine, taking into account the impact on the overall rule set
  • Business Rules Analyst / Business Rules Consultant with experience in harvesting, extracting, and eliciting business rules from SME's. Deep knowledge of Business Rules Methodology
  • Strong analytical skills and quick understanding of complex procedures and processes
14

Information Security Audit & Regulatory Manager Resume Examples & Samples

  • Bachelor’s degree in related field or equivalent combination of education/experience
  • 10 years of Information Security experience or Technology Audit experience or a mix of the two
  • Experience working with internal and external auditors including regulators
  • Professional certificate desirable: CISSA, CISA, CRISC
  • Strong understanding of O&T Risk domains
  • Effective leadership skills
  • Strong written and oral communication skills, including presentation skills
  • Strong understanding of policies and regulations that affect O&T risk control
  • Able to communicate effectively at all levels of the organization
  • Self-motivated, able to manage deadlines in a fast –paced environment requiring strong project management and multi-tasking skills
15

Regulatory Manager Resume Examples & Samples

  • 4+ years of experience in Pharmaceutical Product Development
  • Bachelor's / Master's Degree and/or Ph.D. in Biochemistry, Chemistry, Biology or a related Pharmaceutical field
  • Significant experience in CMC regulatory affairs with a strong Biologics background
  • Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance
  • Experience in directing interactions with Regulatory authorities
16

Regulatory Manager Resume Examples & Samples

  • Follow up that team, cross-functional processes and procedures are easy to follow and complied with in the team
  • Follow up on team objectives to ensure they are met and strategies are implemented
  • Responsible for giving input to the Regulatory Operations budget in collaboration with Head of Submission Management,
  • Communicate decisions and initiatives within the team and in cooperation with stakeholders
  • Ensuring deployment of strategies and targets/KPIs in the section
  • Ensure Submission Execution and Lifecycle Management is in compliance with current regulations and business needs internally and with Sourcing Partner
  • People managing the direct reports
  • Building project management and knowledge sharing capabilities in the Submission Management department
  • Enhancing regulatory and product lifecycle understanding and ways to transfer it into regulatory activities in the department
  • Securing the necessary training and development of employees
  • Provide employees with the needed support to drive performance
  • Organise Induction and training for new personnel in Regulatory Submission Management Dublin
  • Ensure constructive and close working relationships with RA, affiliates, regional offices and our global sourcing partner as well as the manufacturing site
  • Sc. or equivalent third level qualification
  • Minimum of 5 years' experience in the pharmaceutical industry
  • 2+ years' experience within management - resource management, capacity management, target management, performance management, competency development, motivation of employees, situational management etc
  • 3+ years of experience working within different areas of Regulatory Affairs
  • Training within management and leadership
17

Regulatory Manager Resume Examples & Samples

  • Creation of SDS documents for finished products and in-house ingredients
  • Creation of TTB Formulations for applicable products
  • Issuance and maintenance of certificates to comply with NAFTA regulations
  • Ingredient Classification
  • Regulatory support to the Business Continuity Process
  • Execution of SRA Commercialization Review for CPSNA plants
  • Other Regulatory certifications as required by customers and third parties
  • Liaise with Corporate SRA, Legal and Formula Governance teams
  • Advanced Product Formula Knowledge
  • Advanced knowledge of the formula approval process
  • Basic knowledge of food ingredient uses and functionality
  • Basic knowledge of regulatory compliance requirements related to ingredients and formulas
  • Knowledge of Concentrate Plant operation
  • Operational Excellence Knowledge
  • Basic Knowledge of regulations and actions required for the safe transport of hazardous materials
  • Organization and planning
  • Critical, strategic, forward thinking
  • Relationship development and management
  • Clear and succinct communication
  • MS Excel and/or MS Access skills
  • Basic SAP navigation
18

Regulatory Manager Resume Examples & Samples

  • Experience implementing and advising on regulatory/compliance programmes over the past 5 yrs + in the financial services (and commensurate qualifications), call me to discuss
  • An Audit or Compliance qualification (desirable)
  • An understanding and knowledge of Irish Banking Prudential regulation (highly desirable)
  • Strong team player, confident/experienced enough to work autonomously
  • Excellent time management and prioritizing skills
  • Ability to adapt to change and thrive in a dynamic banking environment
19

Business Risk & Regulatory Manager Resume Examples & Samples

  • Identify, assess and analyze operational risk and regulatory topics and define
  • Bachelor / Master degree, preferably in Economics, Law or Business Administration
  • Ability to work under pressure and stringent guidelines and to manage a
20

Compliance & Regulatory Manager Resume Examples & Samples

  • Provision of technical expertise to assist a broad range of clients to manage their relevant regulatory requirements
  • Active involvement in developing new business opportunities and working closely with other departments within the firm to do so
  • A key role in planning and managing projects as required, meeting all deadlines in a timely manner
  • Developing a compliance framework
21

Regulatory Manager Resume Examples & Samples

  • Initiates tracking of the approval process in the Cancer Center database
  • Will follow progress of on-line submission. Will remind investigators to sign off on submission approval if not done within a few days
  • Will promptly initiate response to any IRB stipulations or assist investigators in formulating a response
  • On notice of final IRB approval, will notify café database person so that protocol and Informed Consents can be posted on web site and the set up for patient registration can be initiated. Protocol will also be added to the Protocol Priority List in order for all research staff and investigators to have a list of open trials
  • Gives approved amendments/revisions to database staff for updating the web site
  • At all times, keeps Study File updated for source document tracking (sponsor correspondence, revisions, IRB correspondence.)
  • Notifies research staff of study accrual closure
  • At study termination, closes study in IRB
  • 2 Submits study to the Central IRB (CIRB) with Spanish version of IC
  • 4 Submits signed CTSU form to CTSU
22

Regulatory Manager Resume Examples & Samples

  • Providing advice and assurance on matters of capital, risk management and governance
  • Working with clients to develop or review their ORSA
  • Working with clients to develop or review their reporting requirements under Solvency II
  • Interpreting and preparing for regulatory change; identification of and development of new propositions
  • Advising clients on emerging or identified regulatory themes
23

Regulatory Manager Resume Examples & Samples

  • Prepare and update the CMC sections of global Marketing Authorizations
  • Develop regulatory post-approval filing strategies and prepare CMC variations for global products
  • Prepare CMC regulatory documents accurately, completely and on-time
  • Manage post-approval manufacturing changes for products manufactured at facilities and contract manufacturers
  • Prepare responses to Health Authority queries and requests for CMC information, as appropriate
  • Maintain fluency in emerging global CMC regulations and content/format requirements
  • Support market affiliates with regard to CMC issues
  • Develop strong working relationships and act as primary Global CMC interface with global Regulatory Affairs colleagues and manufacturing sites
  • Work independently (where necessary) through the full-scope breadth and depth in the post-approval CMC discipline
24

Remuneration & Regulatory Manager Resume Examples & Samples

  • Manage in the area of Reward Governance and Regulation, ensuring that appropriate structures, policies and practices are in place across the Region
  • Keeping abreast of regional regulatory issues and evaluating Citi’s remuneration policies, practices and policies against a continuously evolving remuneration regulatory landscape in the UK, across the EU with an understanding of the US regulator’s requirements
  • This role aims to add significant value by contributing to the shaping of Citi’s remuneration policy, processes and practices to ensure compliance from a remuneration regulatory perspective in the UK and across the EU but also remain competitive
  • Evaluating Citi’s remuneration policies and practices against a continuously evolving remuneration regulatory landscape in the UK, and across EMEA with an understanding of the US regulator’s requirements
  • Keeping abreast of regional remuneration regulatory issues
  • Assisting with the implementation of remuneration regulatory requirements and compliance with the UK /EMEA regulators as necessary whilst maintaining Citi’s Global approach to remuneration regulatory issues
  • Key contributor to shaping and application of Citi’s remuneration policy, processes and practices from a UK/EU/EMEA perspective
  • Shaping and developing Citi’s reward structures to ensure compliance with regulatory requirements whilst maintaining Citi’s Global Compensation philosophy and remaining competitive
  • Working closely with the wider Reward team and other internal stakeholders i.e. Risk and Compliance, Reward and Mobility, Legal, and in particular the NY Corporate Compensation Team
  • Training HR colleagues and key stakeholders on practical implementation of remuneration regulatory requirements from a UK/EMEA/US perspective
  • Ability to manage, coach and develop junior members of the team
  • Delivery on annual targets set by HR and Reward and Mobility Management
  • Assisting with audit responsibilities in connection with regulatory remuneration matters
  • Knowledge of UK and global regulatory issues
  • Practical experience of management within a Compensation and Benefits function with regional and/or global responsibilities
  • Proven track record in adding value and delivering on key projects
  • First class client handling and consultancy skills will be vital, given the interaction required with Country HR staff, senior management and multiple businesses across the EMEA region
  • Strong record of achievement and proven success in management of projects involving multiple stakeholders on a regional / global level
  • Management of compliance process on a regional / global level and ability to lead/manage/contribute to negotiations with local Revenue authorities and Compliance / Regulatory bodies
  • Excellent interpersonal, communication and diplomacy skills with the ability to work successfully both as part of a team and on own initiative as well as the ability to inspire confidence from others
  • Pro-active approach to work-load, consistently striving to add value to the business and to contribute to wider Reward and Mobility and HR projects and initiatives
  • Excellent analytical and numerical skills with the ability to effectively review internal / external advice and to make appropriate recommendations to senior management
  • Bachelor degree essential
  • Legal/Tax background would be preferable but not essential for those with relevant experience
25

Cn.legal.specialized.regulatory Manager Resume Examples & Samples

  • 1 LS Creation
  • 2 Maintenance and update of branded tracking sheets
  • 3 Management of bridge stock alerts and customer inventory in case of HP expiration
  • 4 Creation of label master files and label requirements & label artworks and submission to Lachen and FAMO
  • 5 Maintain and extend China Affiliate master file for Travel Retail China
  • 6 Checking of HP status with the local RA Team
  • 7 Reporting on HP status and label availability
  • 8 Checking of label & HP readiness reports
  • 9 Coordinate the Travel Retail Hainan assortment with travel retail regional team
  • 2 Lead projects such as introduction of new brands into China for all regulatory related
  • 3 Be the core communication person for labeling/regulatory with China Affiliate, TR China (different Brand Sales and Education team), TR APAC Singapore Office, TR Global New York Office and Lachen DC
  • 4 Be the regulatory expert for TR China, monitor and track regulatory changes/updates particularly focus on China market information, foresee potential risks if any, and provide function support/possible solutions to internal stakeholders, including Sales team, marketing team, DC team, HR and etc
  • 5 Labeling team daily management
  • 1 Document Travel Retail internal work procedures
  • 2 Ensure all assortments (including Hainan) are HP compliant
  • 3 Sets up annual performance target and development plans with the direct reports and follows up on them
  • 4 supervises introduction and training for new team members
  • 5 Supports the team in daily questions and problems
  • 6 Balances and manages workloads and absences within the team, and act as backup for the Labeling Executives
  • Tertiary education
  • Education and/or experience in Regulatory Matters (HP& Labeling)
  • Experience in a similar role in an international cooperation, and in customs & import regulations preferred
  • Strong communication
  • Fast learner, self-motivated & attention to details
  • Team building ability and coach capability
  • Service minded personality
  • Project Management skills
  • Agility and flexibility
  • Ability to liaise and communicate pro-actively with people of all sorts of backgrounds and levels
  • Face challenges with a fact-driven and professional approach to drive resolution
  • PC literate & good working knowledge in computer applications software
26

Regulatory Manager Resume Examples & Samples

  • Support all regulatory filings and associated activities for clients at the CPUC for Energy Efficiency Programs Funding proceeding and other federal, State or local regulatory agencies, departments, offices and/or funding opportunities
  • Review CPUC proceeding documents (Order Instituting Rulemaking, Administrative Law Judge/Commissioner Statements, Proceeding Scoping Documents, Proceeding Participant Comments/Reply Comments, Draft Decisions, Final Decisions)
  • Review similar documents in other federal, State or local regulatory agencies proceedings
  • Respond to specific requests for data, information or other needs from the CPUC or other regulatory proceeding administrators
  • Provide program-related advisory services related to legislative, regulatory, utility administration, strategic planning , public affairs, fiscal management, and other areas in support of the administration and management of CPUC Programs and in support of activities required for the CPUC proceedings for Energy Efficiency Programs
  • Represent ICF clients, as needed, at CPUC and/or other regulatory agency, federal/state/local offices, and other funding source venues; provide minutes of meetings and updates of these representations
  • Advise a multi-functional project team comprised of technical and marketing specialists (some ICF internal staff and some subcontractors) to ensure timely and professional completion of all tasks and achieve specific program goals
  • Developing and implementing long-term business plans for growing energy efficiency work in the residential, commercial and industrial sectors
  • 10+ years of CA CPUC Regulatory experience supporting, managing, and responding to electric and gas energy efficiency regulatory filings, with experience in residential, commercial, industrial, and/or local government energy issues
  • Experience managing regulatory activities, compliance, and providing representation for projects with public sector clients, including providing quality control and budget accountability
  • Senior level experience in the CA EE market with related energy efficient and renewable technologies
  • Excellent verbal, interpersonal and written communication skills
  • Ability to apply detailed knowledge of organizational procedures to make independent decisions and serve as a credible resource for a senior management team
  • Ability to be flexible to handle multiple priorities
27

Regulatory Manager Resume Examples & Samples

  • Bachelor's degree in Accounting, Business, Computer Science, Economics, Finance, Information Systems or related degree required
  • Seven years’ consulting and advisory experience in the Financial Services Industry (Commercial and/or Retail Banking, Compliance (Consumer Protection and/or AML), Regulatory) or related consulting experience
  • Experience in providing consultation services to financial institutions, particularly banking institutions in one or more area the following areas
  • Consumer Protection Compliance
  • Certified Regulatory Compliance Manager
  • Dodd-Frank Act Compliance
  • Resolution Planning
  • Enforcement Action Remediation
  • Exceptional client service with a demonstrated ability to develop and maintain outstanding client relationships
  • Developing risk management programs, including risk monitoring and reporting, risk assessment and prioritization, and the facilitation of the definition of an organization's risk appetite and risk tolerance in alignment with their organization's strategy
  • Deep knowledge and exposure to corporate compliance engagements, including developing, analyzing and assessing corporate compliance programs; constructing, monitoring and auditing programs; managing internal risk assessment and investigations, collaborating with organization management to integrate compliance controls into the scope of existing business practices; developing and delivering compliance training, and managing incident management systems
  • Ability to participate in the creation and tracking of engagement work plans, timelines, budgets, project management, and resource allocations
  • Maintain active communication with clients to manage expectations, ensure satisfaction, and become a trusted business partner
  • Identifies and addresses client needs: building, maintaining, and utilizing networks of client relationships and industry involvement and communicating the value proposition
  • Strong administrative skills: project workflow, budgets, billing and collections; and preparing and/or coordinating complex written presentation materials
  • Ability to think independently and be a thought leader, professional demeanor, a can-do attitude and other qualities that include decisiveness, self-initiative, and high energy
  • Detail-oriented, able to work according to schedules and workplans, able to ask good questions and request help as needed
  • Examination experience or extensive knowledge with one or more of the following agencies (FRB, OCC, FDIC, FinCEN, or SIFMA) and/or ex-senior AML Officer from a nationally recognized institution
  • 8 – 12 years of relevant experience
  • Able to work with and manage teams of diverse consultants on complex engagements
  • Extensive experience working with and providing advice on KYC / AML and OFAC Sanctions programs
  • Solid knowledge of 1st and 2nd lines of defense
  • Has solid hands on experience working in two or more of the following areas
  • Independent reviews
  • AML and OFAC risk assessments
  • KYC improvement initiatives
  • Vendor solutions in KYC, Transaction Monitoring, Case Management or OFAC
  • Customer risk rating and model validations
  • System validations
  • Bachelor’s or Master’s degree
  • CAMS, CAMS-Audit, or ACFCS certified
  • PMP optional
28

Regulatory Manager Resume Examples & Samples

  • 10-15 years experience
  • Strong marketing and consulting sales skills
  • Superior analytical skills sufficient to enhance large financial institution, banking or capital markets projects
  • Significant examination experience or knowledge with one or more agencies including Federal Reserve System, Office of the Comptroller of the Currency, FDIC, Consumer Financial Protection Bureau, Bank of International Settlements, or equivalent
  • Skilled at coordinating through matrixed management structure
  • Strong people management and project facilitation skills, especially with leading and facilitating teams and guiding transformational change
  • Significant subject matter expertise in the design and implementation of large institution risk management programs in at least three of the areas noted
  • Corporate Governance,
  • Enterprise Risk Management,
  • Market Risk Management,
  • Credit Risk Management,
  • Counterparty Credit Risk,
  • Operational Risk Management,
  • Funding/Liquidity Risk Management and Planning,
  • Capital Adequacy and Planning,
  • Stress Testing (Dodd-Frank),
  • Recovery and Resolution (Dodd-Frank),
  • Compliance Programs,
  • Consumer Compliance,
  • Advanced Anti-Money Laundering Expertise
  • Master’s Degree in business related field (e.g. finance, economics)
29

Regulatory Manager Resume Examples & Samples

  • Manage risk and ensure regulatory compliance by providing support for 3M PI Labs, products, and business teams
  • Work with 3M PI Labs to drive regulatory process requirements
  • Lead global product regulatory compliance and Life Cycle Management (LCM) activities
  • Provide global regulatory consulting/guidance to development/business teams and division to support new products/growth and ensure continuing sales/compliance for existing products
  • Provide customer support – address customer inquiries and data requests
  • Manage division, industry, and corporate expectations around product regulatory data requirements
  • Support global knowledge sharing of 3M PI regulatory trends/requirements by representing 3M on industry teams to track trends & stay abreast of issues affecting 3M PI business
  • Maintain Regulatory Scorecard to track and report division progress
  • Lead U.S. team of direct reports and provide oversight and direction to global regulatory support
  • Drive global connectivity to ensure comprehensive and consistent approach across 3M PI
  • Minimum of five (5) years of experience in a regulatory role
  • Master’s degree or higher in a technical discipline from an accredited institution
  • Product Responsibility Liaison (PRL) internal or similar external experience
  • Minimum of three years supervisory/management experience
  • Experience with healthcare, food contact, and water regulatory requirements
  • Experience with 3M processes and utilization of corporate support (applies to internal applicants only)
  • Ability to work effectively and influence across 3M matrix (internal) or another corporate environment (external)
  • Healthcare business regulatory experience, including pharmaceutical and medical device experience
  • Strong process skillsets
  • Demonstrated ability to champion regulatory process and drive change
  • Experience leading global cross-functional teams
  • Microsoft Office proficient
  • 3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity, age, disability, or veteran status
30

Regulatory Manager Resume Examples & Samples

  • 60% Local Execution
  • Minimum Bachelor degree in related discipline
  • Minimum working experience of 5 or more years in handling product regulatory registration
  • Familiarity with domestic and international regulatory requirements for product registration in Asia Pacific
  • Proven track record of successfully working in an international, multi-cultural environment
  • Proven project management skills and is able to multi-task
  • Excellent command of English language is a prerequisite
  • Incumbent must be a highly motivated “go getter”/”do it yourself”- type of individual with a passion for taking ownership, getting results and making progress
  • Good understanding of product supply chains and organizations involved globally and being able to effectively contribute within these chains and organizations
  • Good business sense and commercial comprehension of the animal feed industry
31

EMC Regulatory Manager Resume Examples & Samples

  • Plans, manages, and develops the EMC and compliance qualification of multiple Head unit and Amplifier programs, requiring both development engineering and execution
  • Manages both internal and external testing, consisting of EMC and compliance testing
  • Coordinate EMC and Compliance Qualification group: coach and lead team towards achievement of group goals; hire, train, allocate resources and develop processes
  • Interface with the entire Product Engineering group to ensure that all necessary qualification activities are included in the project plans and that all planned qualification activities occur
  • Creates test report templates and test plans for all products
  • Interface with other Harman organizations to ensure all qualification issues are resolved in a timely manner
  • Establishes company policy, technical standards, and procedures used in testing our products by keeping abreast of current and new scientific test methods and developments affecting our products warranted by such developments
  • Serves as the technical specialist on EMC and regulatory Compliance testing and support Product Engineering
  • Represents and works to improve Product and Process Quality within Product Engineering teams
  • Must be able to effectively communicate with internal/external customers and internal lab team members and other stake holders
  • BSEE, BSEET, BSCS, BS Physics or equivalent experience
  • 5+ years EMC qualification, 3+ years’ managerial experience, automotive industry background required
  • WORKING KNOWLEDGE
  • Advanced test solutions knowledge for automotive industries
32

Quality Compliance & Regulatory Manager Resume Examples & Samples

  • Lead the implementation of the Food Safety Management system (FSSC 22000)
  • Maintain FSCC 22000 Food Safety Management system
  • Assure compliance with HACCP requirements
  • Assure compliance with Pre-requisites program
  • Ensure training and education for the food security team, as well as for the operators to monitor critical points
  • Ensure compliance to local and federal food safety standards
  • Develop employees through training, annual review, monitoring, and mentoring
  • Maintain a team environment among department and supervisory staff
  • Promote and maintain a safe work environment
  • Work closely with plant operations teams in the areas of quality program management, inspection coordination and testing requirements
  • Maintain current knowledge of trends and changes affecting food safety and develop and recommend appropriate program changes to ensure governmental compliance
  • Advising Management staff of any quality control and food safety issues in addition to presenting plausible solutions
  • Technical knowledge of quality and food safety
  • Experience dealing with regulatory agencies (i.e. FDA)
  • 3-5 years’ experience in Quality Assurance or Food Safety Leadership
  • Experience in developing, maintaining and enforcing
  • Good Manufacturing Practices (GMP)
  • HACCP certification program design and implementation
  • Food Safety documentation and reporting
  • Submitting and implementing corrective/preventive action plans
  • FSSC 22000 requirements
  • Technical knowledge of Food Manufacturing Processes
  • Technical knowledge of Sanitation and microbiology
  • Proficient in Microsoft Office, Meridian, SAP, RedPRerei, KPOG, eQCMS
  • Strong leadership skills
  • Strong verbal and written English communication skills
  • Strong implementation and execution skills
  • Analysis and interpretation of results
  • Good organizational and planning skills
  • Ability to be relatable, personable, and productive within a team environment
33

Regulatory Manager Resume Examples & Samples

  • Bachelors, Masters or University Degree or equivalent in Engineering or Scientific discipline with 10+ years relevant business experience
  • 5+ years of experience in IVD/medical device industry
  • Profound knowledge of international medical device / IVD regulations such as FDA QSR, EU IVDD, MDD, … and related standards such as ISO 13485, ISO 14971, IEC-61010-2-101
  • Experience in establishing and managing a global regulatory strategy (including registrations, product listings / submissions) for medical device / IVD products
  • Demonstrated strong management and leadership skills in implementing program/organization strategies
  • Strong experience in integrating, guiding, and influencing global resources across several complex departments or functions
  • Demonstrates strong teamwork skills and is able to lead, collaborate and work effectively in teams across different businesses, functions and geographies
  • Has a sensitivity for working with other cultures
  • Willingness to work globally within different time zones
  • Technical Knowledge of Product Regulations including Safety, EMC, and Agilent Environmental Standards
  • Experience with Agilent LSAG’s products
  • Experience working in mixed product environment: medical device, pharma, non-medical/clinical regulated
34

Cmc-regulatory Manager Resume Examples & Samples

  • Actively contribute to the development and implementation of regulatory strategy for assigned projects
  • Translate regulatory requirements into practical, workable submission plans
  • Coordinate the authoring, review and comment resolution for related submissions
  • Interface with external regulatory groups, such as contract manufacturers, development partners, consultants and technical writers
  • Act as liaison between Regulatory Affairs and other functional areas
  • Represent Regulatory Affairs in cross-functional team meetings
  • Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments
  • Author and review standard operating procedures (SOPs)
  • Experience working with biologics is highly desirable
  • Experience with regulatory submissions in Common Technical Document format is essential
35

Compliance & Regulatory Manager Resume Examples & Samples

  • Manage a compliance /regulatory team responsible for Compliance activities and Regulatory activities at the site
  • Manage a QA auditor team responsible for lab data review, lab investigations review, methods/protocol approvals and COA issuance
  • Manage/lead audits of Catalent Somerset site to assure compliance with EU and FDA CGMPs, Corporate, and Pharmaceutical Development standard operating procedures and policies
  • Support site in compliance and regulatory matters as required
  • Oversee the process for effectively documenting audit findings in Audit Reports and obtaining responses in a timely fashion
  • Participate in customer audits of the facility as required
  • Liaise with internal and external customers as required for all aspects of audits
  • Act as primary contact with customers for compliance and regulatory matters
  • Oversee and participate in activities in preparing site for inspections by US and foreign regulatory authorities and corporate auditors and participate in these inspections
  • Ensure that written responses are provided and appropriately address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. And those responses are completed as committed
  • Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met
  • Provide overviews of audit findings for presentation to management as required
  • Monitor and oversee the CAPA program, trends, findings, and evaluate CAPA effectiveness
  • Hold regular CAPA meetings with the appropriate departments to ensure completion of CAPAs and their effectiveness
  • Monitor, assess, and report on Trackwise Problem Reports - CAPA, Change Control, Deviations, Follow-ups, and Tasks etc. by meeting with senior level management team on a regular basis
  • Ensure that weekly Trackwise meetings are held and that PR owners obtain resolution for open PRs in a timely manner
  • Ensure that the Trackwise SOPs for all quality systems are current and are being followed by the site as stated
  • Roll out new Compliance programs for the site: creating SOPs and performing training for these programs
  • Provide department quality metrics and tracker information to Senior Management monthly
  • Approve department procedures and assist in the development of new procedures and/or revisions of existing procedures as required
  • Support the Change Control Program ensuring that it meets current regulatory requirements
  • Contribute to process improvement initiatives and represent QA on project teams, management meetings, and other internal forums
  • Review and submit supplements, drug master files, plant/site master files, licenses, registrations, labeling and other chemistry-related submissions to the Federal Food and Drug Administration (FDA), appropriate state authorities, and to foreign regulatory authorities for Catalent and customers’ products as required
  • Assist customers in preparing accurate submissions and responses to the FDA and foreign regulatory authorities as these pertain to the chemistry and manufacture of products manufactured by Catalent-Somerset
  • Compile documents and construct Annual Product Reviews for commercial products manufactured at the Somerset site as requested
  • Participate in customer project meetings, customer complaint meetings, and PR meetings as required
  • Provide timely and accurate reports and assessments of problems or potential problems to the Director, QA
  • Maintain responsibility for interpretation and implementation of CGMP’s and other FDA regulations and pronouncements
  • Provide staff members with leadership, guidance, mentoring, coaching, and feedback against performance and development objectives
  • Assign project assignments to staff members with appropriate due dates for project completion
  • Ensure that departmental goals and project timelines are being met by the team
  • Provide training of personnel as required
  • Compile data for and participate in Management Quality Review Meetings for the site
  • Comply with Health, Safety and Environmental responsibilities for the position
  • Minimum of ten (10) years of experience working in QA/RA areas in the pharmaceutical industry with progressive management responsibilities
  • Compliance in an auditing capacity
  • Some regulatory knowledge is required
  • One to three years of experience in compliance, auditing, and data review
  • Full understanding of FDA and EU CGMPs and DEA regulations pertaining to clinical trial and commercial activities
  • Good understanding of statistics and audit techniques
  • Good communication skills both written and oral are a must
  • Must be well organized and have the ability to multitask
  • Thorough knowledge of CGMPS, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements
  • Good mathematics skills
  • Good Computer skills, including in depth knowledge of MS Office software package
  • Read and understand MSDS requirements and restrictions
  • Understand procedures related to Document Control, Quality Assurance and this job function
  • Requires a good understanding of drug manufacturing and laboratory operations
  • Experience with performing CGMP audits
  • Candidate must have the ability to work effectively under high pressure with multiple deadlines
  • Candidate must be detail oriented with good oral and written communication skills and good interpersonal skills
  • Candidate must have computer skills with a working knowledge with MS Office applications and other software databases
  • Candidate should be a creative thinker with sound business judgment and good negotiation and reasoning skills
36

Regulatory Manager Asia Pacific Resume Examples & Samples

  • Take active role to build regulatory intelligence for Process Solution. Focused area include Single Use as top priority, and will also cover Aseptic Processing, Virus Validation and process materials
  • Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of Process Solutions interests
  • Safeguard Process Solution strategic interests and objectives in arising guidance, standards and regulation
  • Monitor and report on changes of relevant regulatory and compliance environment with impact with Process Solution business. Analyze available regulatory and compliance information
  • Increases the influence of Merck in important regulatory bodies and industry associations
  • Actively participates and represents Merck Life Science - Process Solution in relevant industry associations
  • Effective coordination of strategic activities of Process Solution subject matter experts in local regulatory bodies and industry associations
  • Secure flow of information from/to authorities, industry associations and Process Solution organization
  • Builds and keeps personal relationships to local and national authorities
  • Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards
  • Training for and support of internal stakeholders, external customers and relevant regulatory bodies
  • Provide relevant training to educate local Process Solution marketing/sales colleagues about new regulatory trends and developments that drive our value proposition
  • Builds processes for the flow of information and regulatory intelligence within Process Solution organization APAC
  • Definition of processes to implement upcoming regulatory needs and requirements
  • Support regulatory expertise and consultation for customer regulatory inquiries
  • Closely work with global regulatory surveillance & advocacy team and Process Solution regulatory subject matter experts to link the local advocacy activities with global advocacy activities
  • Monitor competitor approach regarding regulatory requirements
  • Minimum of 5 years of relevant industry experience and/or regulatory affairs related to biopharmaceutical products, pharmaceutical substances and process materials
  • Knowledgeable of CFDA drug regulations and regulatory landscape of other important country/regions (eg. China, Japan, South Korea, EU, US)
  • Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, aseptic processing and validation procedures
  • Knowledge of regulations for Advanced Therapeutic Medicinal Products (cell, gene therapy)
  • Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture
  • Experience working in a global, matrix environment
  • Ability to train and educate others
  • Effective management by influence
  • Some experience in thought leadership
  • Ability to work in multi-cultural teams
  • Good listening skills with the ability to analyze and respond to given situations quickly and effectively
  • Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels
  • Ability to indirectly influence other organizations and cultures
  • Proficient in MS Office Software (Word, Excel, PowerPoint, Project)
37

Regulatory Manager Resume Examples & Samples

  • Process and maintain FDA establishment registrations, FDA device listings, FDA Certificate to Foreign Government, FDA Exportability Certificates, Free Sale Certificates, US state licenses, foreign establishment licenses, global GMP certificates, and other regulatory certificates and licenses.Stacey note: should the OUS role be different in that perhaps it should mention other regulatory standards (For exame CE)
  • Process and distribute regulatory documents with notary, legalization, and/or apostille
  • Proofread, assemble, route, and archive regulatory registration files, as directed
  • Maintain schedule for renewal of regulatory certificates and licenses
  • Process and maintain regulatory quotes, invoices, and other budgetary items
  • Process and maintain requests to complete distributor letters for: distribution agreements, power of attorney, authorizations to register, product lists, market history, etc
  • Process requests and shipments of evaluation units and samples for product registrations
  • Maintain published regulatory records and databases in SharePoint and company document control system (Agile PLM) to ensure latest regulatory approved revisions are presented
  • Support operations, marketing, and sales with global market approvals for product shipments
  • Prepare and maintain general regulatory work instructions as directed
  • Support scheduling and arrangements for regulatory meetings
  • Maintain regulatory library of standards, guidance documents, and regulations
  • Route and/or retrieve regulatory submission records in company document control system (Agile PLM), as directed
  • Perform general typing, data entry, filing, faxing, printing and copying regulatory submission documents, as needed
  • Process and distribute Regulatory Affairs incoming and outgoing mail or shipments
  • Maintain office supplies for regulatory submissions
  • Support Regulatory Affairs team with day-to-day projects, as needed
  • Perform other duties or special projects as assigned
  • Two or more years of experience in quality and regulatory compliance related activities
  • Proficient in Microsoft Office Suite, in particular Outlook, Word, Excel, and PowerPoint
  • Proficient in document and asset management systems
  • Excellent prioritizing, organizational and interpersonal skills
  • Excellent documentation skills including record maintenance/ tracking and understanding of document traceability
  • Willingness to accommodate a flexible working schedule, across many time zones, that may involve evening and weekend working hours depending on project requirements
  • Ability to work in a fast-paced environment, with multiple tasks/projects
  • A detailed-oriented individual with a “can do” attitude and ability to work in a team environment as well as individually with minimal supervision
  • Self-motivated and disciplined
  • Demonstrated ability to work in a matrix environment with non-local and local leadership
  • Excellent English verbal and written communication skills
  • Working proficiency in French or German preferred
  • Able to travel up to 10% of the time, including international travel, as needed to liaise with our Corporate Regulatory team, our international offices and our regulatory agents/partners
  • 3-5 years of related work experience
  • Proficient in document control systems, such as Microsoft SharePoint and Oracle Agile PLM
  • Proficient in data analysis, business intelligence, project management programs
  • Prior experience working with international organizations
  • Prior experience working with legal counsel or regulatory body agencies
  • Prior experience working within a medical device company
  • Prior experience working with operations and/or marketing teams
38

Global Program Regulatory Manager Resume Examples & Samples

  • Serves as regulatory representative to early clinical development and research project teams and to government regulatory agencies
  • Provides strategic regulatory direction to teams on submission strategy, interaction and negotiation with regulatory agencies. Serves as a regulatory liaison on the project team throughout early development
  • Provides advice to teams on several aspects of drug development based on appropriate regulations and their interpretation
  • Ensures that pre-clinical and clinical trial designs meet regulatory requirements
  • Supports the successful completion of major programs and may function in a project leadership regulatory role
  • For projects assigned as DRA Lead, lead the development of submission of clinical trial applications world-wide, progress reports, amendments, and/or periodic experience reports. Provides regional regulatory expertise (strategic and operational) to other DRA Leads
  • Ensures rapid and timely approval of clinical trial applications
  • May interact and negotiate with regulatory agency personnel in order to expedite approval of pending applications and answers any questions
  • Coordinates, reviews, and may prepare reports for submission. Coordinates and maintains reporting schedules for assigned compounds
  • Participates in one or all of the following activities: early development plan, regulatory strategy, risk management, implementation plan, and chemistry manufacturing control (CMC)
  • Develops technical solutions to complex problems which require the regular use of ingenuity and creativity
  • Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective for desired results
  • May represent organization as prime technical contact on contracts and projects. May interact with senior external personnel on significant technical matters often requiring coordination between organizations
  • Effective matrix management of interfaces with DRA staff, DRA operational staff, CMC regulatory and external collaborations
  • 3-4 years of regulatory experience, preferably with a strong knowledge of US regulatory affairs. Additional knowledge of other regions is an asset
  • Oncology background highly preferred
  • Additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline is an asset
  • Involvement in an IND/CTA submissions and approval
  • Experience with HA negotiations
  • Innovation and strategy
  • Experience working in matrix environment or cross-functional teams
  • Strong interpersonal, communication, negotiation and problem solving skills
39

BB&T Securities Regulatory Manager Resume Examples & Samples

  • Coordinate with Corporate Compliance in the updating of firm’s WSPs as needed
  • Work collaboratively with the branch system on all aspects of the supervision function related to BB&T Securities
  • Update retail and institutional department procedures as needed
  • Ensure proper licensure and registration of retail and institutional associates and branch offices
  • Ensure traders follow the firm’s policies with regards to markups/markdowns by monitoring daily trading activity
  • Ensure all retail and institutional branch and home office associates follow policies regarding personal trading, outside accounts, political contributions, outside business activities and outside investments
  • May serve as a liaison between the firm and external auditors and Self-Regulatory Organizations
  • Oversee business recovery plans for Capital Markets, Private Client Group and Sterling Advisors
  • Chair the Regulatory Committee to determine the impact new rules and regulations have on the firm, provide the opportunity for the firm to comment on a proposed rule and build awareness of new regulations to those that will be most affected
  • Oversee regulatory governance with Financial Industry Regulatory Authority (FINRA), Municipal Securities Rulemaking Board (MSRB), Securities & Exchange Commission (SEC), Federal Reserve Bank (FRB), and other relevant governmental agencies
  • Oversee and perform outside account reviews
  • Collect employee trade pre-approvals and review employee and employee-related trading in the Protegent system
  • Manage Compliance with the U.S. Department of Labor Conflict of Interest Rule requirements
  • Seven years of financial services industry experience
  • Excellent analytical, problem-solving, organizational, and communication skills
  • Ability to effectively communicate with senior management utilizing written and verbal communication skills
  • Hold required FINRA Securities licenses (or able to be obtained within one year): 7, 8 (or 9/10), 24, 53, and 63 (or 66)
  • Ability to manage confidential material competently
  • Ability to travel, occasionally overnight, to industry conferences or for other business reasons
  • Good interpersonal, negotiating and problem-solving skills
  • Master of Business Administration (MBA) or other related graduate degree
40

Accreditation & Regulatory Manager Resume Examples & Samples

  • Technical support for regulatory, accreditation and contractual(payer) compliance, including coordination of Joint Commission
  • Compile high level Joint Commission readiness reports on a monthly basis for the purpose of senior level reporting
  • Reviews Policy and Procedures to assure regulatory compliance
  • Responsible for coordination of accreditation committee, including assignment of Joint Commission readiness for each team
  • Staff various standing committees such as policy development and regulatory compliance, to assure support, discussion, documentation,
  • Liaison to the Medical Staff Department, Medical Records Department, and other various departments to assure ongoing regulatory compliance
  • Performs other related duties as assigned or directed
  • Knowledge of regulatory, licensing and accreditation requirements
  • Knowledge of organizational learning methods
  • Knowledge of group facilitation techniques
  • Proven written and oral communication skills
  • Computer use skills to include: word processing, reports, statistics, graphs using various tools, e.g. Excel, Access, etc
  • At least 3 years experience with accreditation and licensing survey preparation and implementation in a healthcare setting, as guided by Joint Commission, CMS, payer requirements and metrics
41

Eemea Hub Technical Regulatory Manager Resume Examples & Samples

  • Act as primary technical regulatory (CMC) point of contact for the Affiliate DRAs and work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network
  • In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Eastern Europe, Middle East and Africa (EEMEA) markets associated to CMC changes originating at Roche/CMO manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities
  • Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility
  • Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert)
  • Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility
42

Safety & Regulatory Manager Resume Examples & Samples

  • 10+ years’ experience working in a logistics or manufacturing environment
  • 5+ years’ experience in a Safety / Regulatory role in a logistics or manufacturing environment, including internal and external audits
  • Bachelor’s Degree in a technical discipline (e.g. Chemistry, Chemical Engineering, Biology) or Operations Management / Supply Chain Management
  • Previous experience with personal safety and behavior-based safety programs
  • Experience with hazardous materials (e.g. ethanol used in hand sanitizers) and process safety management
  • Previous experience working in a TPM environment
  • 3+ years’ experience in cross-functional project or program management
  • Certification as a Safety Professional
43

QA & Regulatory Manager Resume Examples & Samples

  • Develop and maintain the Quality Management system for the Healthcare sites in Duluth and Beaverton and ensure compliance to the medical device quality standards (ISO13485, FDA CFR Part 820, …)
  • Master’s degree in a technical field or an equivalent combination of experience and education
  • Proven experience in quality management(QMS) for medical devices with an absolute minimum of 5 years in a leadership role
  • Qualified auditor for ISO 13485 and FDA QSR
  • Excellent knowledge about active Medical Device QMS requirements for (MDD, FDA CFR part 820, Canada Health, …)
  • Excellent knowledge on FDA recall and reporting obligations
  • Excellent leadership and teamwork; demonstrated ability to motivate others, work as a team and take ownership where required
  • Good analytical skills to identify trends from different data sets
  • Willingness to perform limited travel per year (short travel)
  • Knowledge of business principles and basic financial analysis
  • Knowledge of SAP or similar ERP systems and basic knowledge of Business Intelligence Reporting
44

Financial Services Risk & Regulatory Manager Resume Examples & Samples

  • Development of solutions related to strategy, operations and management in a number of functional areas of corporations or start up companies
  • Corporate compliance, including developing, analyzing and assessing corporate compliance programs; constructing, monitoring and auditing programs; managing internal risk assessment and investigations, collaborating with organization management to integrate compliance controls into the scope of existing business practices; developing and delivering compliance training, and managing incident management systems
  • Management of multiple, complex projects and direct medium to large staff teams
  • Communicating with external clients and internal staff in an organized and knowledgeable manner
  • Leveraging project management and project facilitation skills, especially with leading and facilitating teams and developing client proposals
  • Identifying and addressing client needs: building, maintaining, and utilizing networks of client relationships and community involvement; communicating value propositions; managing resource requirements, project workflow, budgets, billing and collections; and preparing and/or coordinating complex written and verbal materials
  • Developing risk management programs, including risk monitoring and reporting, risk assessment and prioritization, and the facilitation of the definition of an organization's risk appetite and risk tolerance in alignment with their organization's strategy
45

Regulatory Manager Resume Examples & Samples

  • Communication with HA and follow up registration review and testing process to obtain the approval duly
  • Provide regulatory strategy to business partner to support new project development and existing product continuity
  • Work with regional franchise team on regulatory strategy development, provide innovative regulatory solutions
  • Monitoring external regulatory environment, shape business opportunities and challenges
  • Well manage registration and regulatory database, timely update and maintain document in a good manner
  • Other harmonization work in RA department
46

CMC Regulatory Manager Resume Examples & Samples

  • Supports and leads the preparation of CMC information for submission to global regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans
  • Global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions
  • Accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of commercial products
  • Creates and contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the portfolio at large
  • Leads document management and information management teams, within Global CMC / groups outside Global CMC
  • Serves as a Global CMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies
  • Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation
  • Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control
  • Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the pharmatherapeutic portfolio. Manages the resolution of regulatory CMC/information management issues with project/program stakeholders
  • Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate
  • Collaborates across Global CMC and functional activities in a matrix environment, with globally located cross-functional project teams including representatives from World Wide Pharmaceutical Sciences / Worldwide R&D / or Global Supply. Teams may include PSPTs, Co-Dev Teams and Manufacturing Lifecycle Teams
  • Interactions with regulatory agencies and/or external partners maybe required (either directly or in conjunction with Regulatory Affairs Department). May participate in pharmaceutical industry initiatives and support the development of positions to external regulatory policies
  • Degree in Science or similar
  • Experience in regulatory CMC is essential
  • Expertise in pharmaceutical science development or biopharmaceutical manufacturing and/or specific regulatory domain
  • Ability to interpret and apply global / regional CMC regulatory policies and requirements for assigned projects
  • Strong knowledge of pharmaceutical sciences, the pharmaceutical industry, and a clear understanding of drug development/commercial manufacturing of pharmaceutical products
47

Safety / Regulatory Manager Resume Examples & Samples

  • Take the lead role in running the Fair Lawn safety program, inspiring a culture where employees take ownership for safety. Engage employees in safety initiatives to eliminate or control safety hazards and reduce risk of injury or chemical release
  • Implement a comprehensive EHS inspection program and track corrective action items to completion
  • Ensure proper safety training for existing and new personnel
  • Conduct incident investigation and root cause analysis. Ensure injury and illness cases are effectively managed to closure
  • Manage the site Emergency Plan and Emergency Response Team. Provide or make arrangements for First Aid, CPR/AED and HAZWOPER training
  • Interface with other Regulatory Support personnel such as the Process Safety Engineer to ensure all aspects of site safety are addressed in Fair Lawn
  • Lead in ensuring compliance with HazMat (DOT, IMDG, IATA) regulations and practices by Fair Lawn and Bridgewater personnel
  • Periodically audit areas for compliance, developing action items to improve compliance in a continuous improvement effort
  • Provide interface for auditing/inspection government agencies, corporate inspectors and customer auditors
  • Provide technical/regulatory EHS guidance for chemical handling, ergonomics, lockout/tagout and other EHS programs
  • Provide other regulatory support as needed
  • IND-LPG
48

Regulatory Manager, Personal Care Resume Examples & Samples

  • Manage the provision and interpretation of regulatory information to both internal and external customers
  • Provide guidance and direction for responding to regulatory developments
  • Manage and maintain relationships with key industry trade bodies, industry consortia and regulatory agency officials
  • Maintain expertise in relevant EU regulations on personal care and a good working knowledge for other regions to ensure delivery of a high standard of service
49

Regulatory Manager Resume Examples & Samples

  • Experience in building global regulatory strategy/teams
  • Ability to adapt regulatory knowledge/experience to the Agilent environment and develop solutions that are appropriate for Agilent
  • Active listener that approaches challenges with an open mind
50

Real Estate Regulatory Manager Resume Examples & Samples

  • Bachelor’s degree and a minimum of 5 years experience in the wireless telecommunications industry in positions of increasing scope and responsibility
  • Strong knowledge of wireless industry including real estate, construction, transport, operations, and RF/System Performance functions
  • Strong leadership and organizational skills and the ability to develop, manage and track the execution of multiple projects simultaneously
  • Demonstrated ability to lead, motivate and coach large diverse teams toward common goals and objectives
  • Must have demonstrated ability to deliver quality results and to meet or exceed objectives while working in a fast paced environment
  • Excellent written and verbal communication skills. Responsible for communicating effectively at all levels
  • Excellent project management skills and a demonstrated ability to deliver upon commitments, goals and objectives
  • Proficient in Microsoft Office Suite (PowerPoint, Excel, Word)
  • Strong conflict resolution and negotiating skills
  • Highly autonomous
51

Flavor Regulatory Manager Resume Examples & Samples

  • Manage flavor information, including maintaining current flavor-related database information
  • Assess regulatory compliance of flavor materials and related consumer product and labeling issues
  • Act as regulatory expert and consultant in flavors and related areas, with internal and external partners
  • Establish, communicate, and enforce policies regarding flavor regulatory issues
  • Develop and maintain relationships with internal and external partners
  • Work with internal and external partners on flavor regulatory and policy issues
  • Create flavor training modules and train internal and external stakeholders
  • Knowledge of the regulatory approach to assessing the appropriateness of flavors (regulatory position, 3-5 years)
  • A foundation of scientific training sufficient to support scientific and regulatory flavor evaluation efforts and discussions (4-year science degree or Masters)
  • Knowledge of the flavor industry and experience in dealing with flavor suppliers on confidential regulatory matters (3-5 years)
  • Intense attention to detail is a must
  • Ability to recognize and address regulatory and trade secret issues that arise in casual exposure or in the course of research work
  • Ability to gather and manage detailed, sensitive information relating to regulatory status of flavor materials in various countries
  • Ability to gather and manage flavor regulations from various countries
  • Ability to interpret regulatory information so that it can be readily used in decision making
  • Must be conversant with global regulatory climate, including major markets, and comfortable in identifying and assessing regulatory situations in all markets
  • Ability to reduce volumes of information to a cogent position or recommendation
  • Sufficient computer knowledge to use formula system, and spreadsheet/database software to capture, manage, condense, and retrieve regulatory information
52

Junior Global Program Regulatory Manager Resume Examples & Samples

  • Serves as DRA representative on product sub-teams as needed
  • Contributes to preparation and finalization of Briefing Books
  • Coordinates responses to HA requests
  • Assists with the preparation, Quality Control, and submission of original worldwide dossiers and maintenance submissions
  • May ensure the timely availability of supporting documents (e.g., GMP certifications, registration samples etc.)
  • Coordinates regulatory activities and submits CTAs and INDs with Global Program Regulatory Director or Global Program Regulatory Manager supervision
  • Acts as main liaison with DRA Operations to ensure accurate and timely submissions to HAs
  • Prepare Annual Reports and renewals and ensure on-time submission to HAs
  • Enter product specific attributes as provided by DRA GPT representative into compliance database
  • Support regulatory compliance activities for projects and keep records of all major HA interactions in the validated document management system
  • Provide support as needed for non-project related regional excellence activities
53

Global Program Regulatory Manager Resume Examples & Samples

  • Experience with regulatory submission and approval processes in one or more major regions
  • Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry
  • Experience in HA negotiations
  • Min. 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas
  • Understanding of post-marketing/brand optimization strategies and commercial awareness preferred
  • Involvement in an dossier submissions and approvals
  • HA negotiations
  • Drug regulatory submission and commercialization in region
  • Analysis and interpretation efficacy and safety data
  • Basic organizational awareness (e.g., interrelationship of departments, business priorities)
54

Product Stewardship & Regulatory Manager Resume Examples & Samples

  • Prepare and/or oversee compilation of regulatory dossier submissions to EU and other EMEA Animal Feed authorities, in conjunction with global product stewardship & regulatory staff
  • Manage EMEA regulatory compliance for IB products touching the animal feed industry, in conjunction with global regulatory & product management staff supporting animal nutrition and grain/feed processing industries
  • Define approaches and procedures on new assignments and provide guidance to other staff
  • Translate goals of the company into a strategic plan for his/her areas of regulatory responsibility
  • Responsible for communication of regulatory strategies and policies, and implementation
  • Influence regulatory/product stewardship policy externally with trade associations (FEFANA, Amfep) and authorities (EFSA, EU Commission, country regulators)
  • LI-CW1
  • In depth knowledge and recognized for leadership & innovation in managing animal feed regulatory or similar program
  • Successfully impacted product introductions by providing regulatory guidance and/or successfully influenced decisions at plants to implement change
  • Successfully implemented complex/controversial regulatory policies and strategies, and systems to improve data communication
  • 8-12 years of experience desired
55

Private Brands Regulatory Manager Resume Examples & Samples

  • Ensures that all product labels developed for the Supervalu Private Brands group are legally compliant for ingredient listing statements, nutritional content, marketing terminology, and provides recommendations for compliance options
  • Conducts regulatory research and provides support to ensure products meet regulatory requirements, including implementation of new label regulatory requirements
  • Assess and grade manufacturing partner regulatory resources; develop streamline regulatory compliance model that minimizes risk
  • Partners with regulatory agencies, product suppliers, Supervalu internal resources and regulatory industry professionals to stay current on regulatory issues with food and non-food products
  • Makes pro-active recommendations for Private Brand items with reference to pending regulatory requirements (state and federal)
  • Ensure Prop 65 compliance for Private Brand products sold in California
  • Reacts to regulatory non-compliance issues; working with internal and external partners to amend the compliance issue
56

Regulatory Manager Eame Resume Examples & Samples

  • Develop and implement robust regulatory strategies to support L&G-related portfolio of assigned active substances and products in EAME through
  • Scientific background in one of the disciplines relevant for regulatory
  • Good understanding of regulatory and political processes in the EU and in EU MS
  • Knowledge of relevant regional regulations and legislation specific to Lawn&Garden, including adjacent legislation
  • Effective team worker and good communicator
  • Negotiation and advocacy skills
  • Planning, project management and issue management skills
  • Delivery of quality work, even under time pressure
  • Curiosity, openness and willingness to challenge the accepted ways of working and to implement new ones
  • Coaching and development of team members
  • Fluent in English in technical discussions and advocacy
57

Regulatory Manager Resume Examples & Samples

  • Achieve, extend and maintain license to sell (registrations) for Syngenta products in AME (Africa/Middle East)
  • Provide regulatory expertise to the business
  • Plan and execute regulatory activities in AME and find innovative registration approaches within the legal regulatory framework
  • Manage all registration activities for a set of countries in the territory. This includes the preparation of registration submissions; answering requests from authorities; covering regulatory aspects of product labelling and formulation/source changes; keeping Syngenta internal registration databases up to date
  • Provide regulatory expertise and foresight to the business. Keep regulatory and business informed on regulatory changes and emerging issues which require proactive management
  • Provide annual plans, timelines and budget needs for all registration activities in-line with portfolio strategy/priorities. Track, review and report registration progress against targets
  • Establish a network with regulatory authorities, represent company interests and shape the local regulatory environment. Maintain close contact to local partners in order to grow and maintain expertise of national registration processes and legislations
  • Proactively manage product related issues, stewardship activities
  • Support supply chain on regulatory matters (shelf-life extensions, country of origin issues, review of inspection certificates, etc.)
  • Cover regulatory aspects and the coordination of the internal PS&RA governance process
  • Degree in Science or relevant technical qualification
  • Good knowledge of regulatory requirements in the crop protection industry; gained through direct experience in a regulatory role; or through significant technical experience
  • Demonstrated strengths in communication, self-organization and problem solving and developed negotiation/influencing skills across different cultures
  • Excellent team working, project management and interpersonal skills
  • Sufficient regulatory experience to be able to work autonomously
  • Attention to details and ability to complete and deliver tasks on time
  • Show ability to work accurately and to deliver dossiers/special tasks on time and up to Syngenta standards
  • Good communication in English, French would be a plus
58

Regulatory Manager Resume Examples & Samples

  • Supports the local study team in preparation of trial documents for regulatory submission
  • Submits CTA and any other documents required regulatory submission to the local Regulatory Authority
  • Follows up the regulatory approval progress and ensures that submissions are performed in a timely manner, follow import/export licenses obtaining (if applicable)
  • Ensures that the trial documents provided to the application for regulatory approval and obtaining of regulatory approval for clinical trials are carried out in accordance with local rules and regulations, and that product information given to Regulatory Authorities is the most recent and updated
  • Acts as liaison with local Regulatory Authority
  • Maintains a file of country specific regulations, requirements, procedures, and etc., which are relevant to clinical trials and informs GCO Ukraine employees on any changes in a timely manner. Provides Local Trial Manager with trial-specific correspondence with Local Regulatory Authorities
  • Represents the company and the organization adequately to the customers and other external parties
  • Conducts business in line with the HCC, company policies and procedures, including applicable SOPs, always having the ethical aspect in mind
  • Maintains adequate communication with relevant parties within and outside the company
  • Complies with ICH-GCP and all applicable local laws and regulations
  • Actively follows trainings to ensure adequate qualification for performing job-related tasks
  • Reports (suspicion of) fraud or scientific/ethical misconduct as appropriate
  • Regularly updates information in applicable systems and templates
  • Contributes to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards continuous quality improvement
  • Maintains quality standards and timelines that are consistent with business needs
  • Minimum of 3 years’ experience in the pharmaceutical industry, at a CRO including extensive clinical research experience
  • Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment
  • Strong interpersonal and negotiating skills, exelent communication skills
  • Strong knowledge of MS Office.Clinical Data Management
59

Legal / Regulatory Manager Resume Examples & Samples

  • Provide oversight for Legal / regulatory requirements for CTI EMEA and CIS entities
  • Act as a key CTI point of contact for all legal/regulatory items
  • Support Risk and Controls team in disseminating regulatory updates to CTI EMEA and CIS entities and assessing the impact of these regulatory changes for entities/countries within the region together with Risk Managers
  • Key CTI point of contact for the external / regulatory audits for CTI EMEA teams to ensure no surprise findings or finding due to lack of communication or management of the audit requests. Liaises with external and regulatory auditors when appropriate
  • Oversight CTI EMEA and CIS entities for the governance of legal and regulatory requirements including, but not limited to, Cross-border, Data Privacy and SOX programs
  • Maintains a professional oversight of issue remediation activity for entities within the assigned area
  • Works collaboratively with the CTI EMEA and CIS Risk and Control Department to develop and execute the strategy for legal and regulatory requirements. This includes driving our supported teams across CTI towards an External Audit Ready/ Regulator Ready state, where processes and key risks are well understood and controls to manage risks are fully implemented and measured
  • Manages oversight of the effective disclosure, recognition and subsequent closure of control issues within the entities supported
  • Attend operational management meetings as required for the entities supported
  • Design and develop controls for CTI relevant legal/regulatory requirements to ensure that CTI EMEA and CIS functional entities are meeting strategic goals
  • When required engage with global teams and risk management teams on key control issues
  • Continually seek to leverage process improvement opportunities
  • Work with the various Global and Regional Risk and Control heads to ensure a robust operational risk framework is embedded for all the represented functions in the Budapest Centre
  • Provide input to the CTI EMEA and CIS Risk and Control Management Meeting in legal/regulatory updates, issues on an ad hoc basis
  • Understanding of Controls environment, Risk based thinking and Information security principles
  • Process definition and creation, including document control
  • External/regulatory Audit and/or risk management experience is essential
  • Ability to plan, organize, monitor workload and priorities across multiple groups
  • Understanding the legal / regulatory compliance processes
  • Proficiency with all MS Office products
  • Excellent interpersonal and written skills
  • Contributor with strong drive and self-starter attitude
  • Strong work ethic and excellent use of discretion and judgment
  • Analytical approach with an eye for detail and emphasis on accuracy
  • Act with urgency , courage and conviction
  • Be accountable – own the outcome
  • Act with integrity – do what is right
  • Strong organizational ability
  • Proven leadership skills
  • Ability to build strong relationships between businesses and across countries
  • Excellent level of written and spoken English
  • Experience of the reporting and analysis at a project / senior management level
  • Professional IT or Risk qualification. CISA , CISM and/or CRISC [Preferred]
  • Relevant leadership or project management/operational experience
60

Quality / Regulatory Manager Resume Examples & Samples

  • Performs the day to day audit and quality assurance functions within the training center
  • Performs all scheduled quality monitoring activities (including internal audits, management evaluations, inspections, supplier audits, etc.,)
  • Establishes (through quality monitoring), performs follow-up and ensure closure of corrective and or preventive actions
  • Implements Continuous Improvement activities under the guidance of the Accountable Manager and other responsible managers
  • Ensures that the system monitors the processes put in place to ensure regulatory compliance and to inform the Accountable Manager of its performance and all necessary remedial actions
  • Identifies and records any concern or findings and the evidence necessary to substantiate such concerns or findings
  • Follow up internal audit corrective and or preventive actions, verifying the satisfactory implementation of solutions within the specified time frame
  • Implements, monitors and coordinates improvements to the Quality and Regulatory System
  • Verification by monitoring the activity in the fields of training device qualification and training, that the standards required by the authorities are being carried out under the supervision of the relevant manager
  • Ensuring that the quality assurance program is properly established, implemented and
  • Managing the operation of the quality system
  • Organizing, executing and reporting the Quality Monitoring Program to verify that standards and rules are complied with
  • Monitoring, following up and evaluating the implementation of corrective actions that may arise from quality inspections, audits and management evaluations
  • Provide management with an independent assessment of corrective and preventive actions, their implementation and completion
  • Maintaining records of completed audits, non-conformities and corrective and preventive
  • Edition, amendment, distribution and updating of the quality documents
  • The implementation and monitoring of the quality system
  • Programming, supervising and recording the conduct of Quality Audits to verify that standards and rules are complied with
  • Coordinating improvements to the quality system
  • The overall function of the Quality Manual
  • Ensuring that follow-up action within an agreed time frame is taken in respect of any non- compliance
  • Maintains records of completed audits, non-conformances and corrective and preventive actions
  • Performs annual Quality and Regulatory updates briefing to the personnel of the training center
  • Maintains all reports and records related to the Quality procedures to provide evidence of the effective operations of the QMS at the center
  • Planning and coordinating of annual instructor assessments and organization of standardization meetings in collaboration with the Head of Training
  • Liaise with External Auditors
  • Liaison on Quality and Regulatory matters concerning the Quality and Regulatory plan
  • Liaison with Head of Training and Instructors to prepare and publish training plan for the Training Group
  • Responsible for inputting amendments to the manuals
  • Keep informed about the Philippine Civil Aviation Regulations and any changes thereto as well as the internal policies of CAE in relation to operating an Aviation Training Organization, Pilot Licensing and Simulator certification among other matters and ensure compliance
  • As part of Regulatory oversight, handle all Environment, Health & Safety related matters and ensure compliance with the PCAR and relevant CAE internal policies
  • Be the designated SMS Manager
  • Other duties that may be assigned
61

Quality & Regulatory Manager Resume Examples & Samples

  • Work with global and local Quality network members to deploy an effective internal and external audit programme and maintain those processes and systems necessary to maintain our ISO9001 certification
  • Liaise with BSi regarding the external certification audit of our activities and the coordination of improvement actions associated with audit findings
  • Work with global and local regulatory network members to deploy an effective vigilance programme for IVD products and reagents ensuring compliance with internal quality regulations and the In-vitro Medical Device Directive
  • Liaise with the Medicines and Healthcare Regulatory Authority regarding the management of in-field vigilance actions including field safety corrective actions and reagent recalls
  • Work with Managed pathology development teams to ensure compliance of customer oriented managed pathology service solutions with ISB0129 and the In-vitro Medical Device directive
  • Work with other Local Quality and Technology team members to raise the awareness and engagement of staff in the Healthineers Principle, ‘No Compromise on Quality&#8217
  • Essential: Detailed understanding of ISO9001 and a track record in implementing and managing an ISO9001 certified management system in a medical device environment
  • Essential: Understanding of those elements of the IVDD that apply to the operations of an in-vitro diagnostic device sales and service provider
  • Essential: Understanding of those elements of the MDD that apply to the operations of an in-vivo medical device sales and service provider
  • Essential: Understanding of product safety principles and the operation of I-Field Medical Device Vigilence systems
  • Useful: experience in operating customer complaint and Corrective And Preventative Action, CAPA systems
  • Useful: experience in liaison with regulatory authorities including the UK Medicines and Healthcare Regulatory Agency
  • Useful: knowledge of process improvement tools and techniques including the application of lean
  • Useful: knowledge of NHS ISB0129 Clinical Risk Management: Application in the Manufacture of Health IT Systems - Post Implementation Review
  • Useful: knowledge of the European Foundation Quality Management Model
62

Regulatory Manager Resume Examples & Samples

  • Achieve, extend and maintain license to sell (registrations) for Syngenta products in Zambia
  • Plan and execute regulatory activities in Zambia and find innovative registration approaches within the legal regulatory framework
  • Support all regulatory activities in Tanzania
  • Manage all registration activities for Zambia and provide support to Tanzania. This includes the preparation of registration submissions; answering requests from authorities; covering regulatory aspects of product labelling and formulation/source changes; keeping Syngenta internal registration databases up to date
  • Ensures, in coordination with and support from the technical lead, registration trial protocols are developed in a timely manner, registration trials are set up and followed continuously for assessment and report writing (if required)
  • Good knowledge of regulatory requirements in the crop protection industry for Zambiagained through direct experience in a regulatory role; or through significant technical experience
  • Good communication in English and local languages
  • Travels to Tanzania and other countries within territory if needed
63

Hazard Communication Regulatory Manager Resume Examples & Samples

  • Provide expertise to guide the business in finding solutions to hazard communication and chemical regulation compliance issues that affect our products, ingredients, and labels. Ensure information in Master Database related to hazard communication is accurate and current based on available information
  • Maintain a strong network of experts, government agencies, industry peers and other stakeholders needed to maintain a favorable regulatory environment for the company. Represent the company externally on relevant trade and scientific organizations
  • Influence, review and monitor new/changing global regulations so that leadership can be proactively informed of emerging hazard communication and chemical regulatory issues that are an impact to the business and identify strategies to address them. Interpret, assess business impact and implement new regulations as required
  • Partner with the business and internal manufacturing to identify needs to meet current and future requirement for hazard communication
  • Direct the activities of the team and provide leadership and motivation including coaching and mentoring team members
  • Experience in the fields of hazard communication, Safety Data Sheets, and transportation classifications, preferably with a flavor/fragrance, consumer product or chemical company
  • Working experience with hazard communication regulations
  • Communication Complexities
  • Judgment and Decision Making
  • Expert knowledge of Global Health and Safety regulations
64

Communication & Regulatory Manager Resume Examples & Samples

  • > Regulatory and Quality management
  • Establish and build relationships with key stakeholders internally and externally,
  • Implement global strategy of Regulatory and Quality functions on CBU level,
  • Successful implementation of global Regulatory and Quality projects,
  • > Nutrition Science and Public affairs
  • Cooperate with other functions providing them nutritional expertise,
  • Provide nutritional expertise in external relations,
  • Coordination of timely approvals and validation of communication and artworks in Baltics,
  • > Build functional capabilities and develop self & others
  • Develop and educate self and team,
  • > Core processes & routines
  • Communication and artwork validation,
  • Timely product notifications, registrations and reimbursements in Baltics,
  • Nutrition Science expertise in projects,
  • Crisis management & risk assessment,
  • Product notifications, registrations & reimbursement,
  • Complaint handling, Quality reporting,
  • Budget management of the area
  • Academic background, university degree in medical/ nutritional/ legal sciences as well as some significant experience in the field or related areas,
  • Ability to manage complexity,
  • Effective stakeholder management (networking & management)
  • Coaching and training skills,
  • Project management ability and medical credibility,
  • Strong ability to understand and identify opportunities,
  • Presentation skills and desire to develop oneself,
  • Achievement oriented, flexible, agile, personable and pragmatic,
  • Strong problem solving skills and self-motivated,
  • Able to deal independently with unexpected changes,
  • Team player with coaching and training skills,
  • Excellent languages skills: Latvian and English as well
65

Senior Technical Regulatory Manager Small Molecules Marketed Products Resume Examples & Samples

  • Provide strategic leadership and regulatory decision making for synthetic marketed products in cross-functional product team
  • Develop global Chemistry and Manufacturing Controls (CMC) regulatory strategy
  • Manage the generation of high quality regulatory submissions required for the filing of technical changes, renewals and clinical trial applications to health authorities globally
  • Interact with management from multiple internal functional areas, corporate partners, manufacturing sites and international affiliates
  • Facilitate the effective and rapid implementation of technical changes
  • Negotiate successfully with affiliates, partners and health authorities
66

Regulatory Manager Resume Examples & Samples

  • Responsible to ensure compliance with all Federal, State, County and Town Permits
  • Responsible for SPDES Compliance
  • Responsible for MPFL/CBS (Major Petroleum Facility License/Chemical Bulk Storage) Compliance
  • Responsible for Hazardous/Non Hazardous Waste storage. Disposal and record keeping
  • Responsible for OPA 90 Compliance (Oil Spill Response/Drills)
  • Responsible for site Emergency Plan and Environmental Compliance procedure review updates
  • Responsible to Administer Tuesday Morning Safety Brief and monthly Safety Committee meetings
  • Responsible to administer Contractor Safety requirements
  • Responsible for 33 CFR 105 (MARSEC Security Requirements)
  • Act as Site Facility Security Officer
  • Responsible for site NERC CIP Security Requirements
  • Responsible for the Operation of the site Waste Water Treatment Facility
  • Responsible for the Station Clerical staff
  • Must be available for immediate consultations by colleagues’ beyond normal work hours
  • On a rotating basis, acts as a Division Standby Supervisor who responds to after hours request for maintenance assistance
  • The incumbent will act as the company's spokesperson with regulatory agencies. As such, excellent interpersonal and managerial skills are required
  • The incumbent must have proven ability to act independently
  • Knowledge and a good working understanding is required in the areas of thermodynamics and fluid mechanics
67

Regulatory Manager, Food Resume Examples & Samples

  • Handle all US regulatory issues for (new and existing) food ingredients for Bakery, Processed Meat, Harvest Intervention, Dairy, Beverages and sugar Confectionary
  • Check US regulatory (FDA/USDA) compliance by regulatory audits
  • Project management of special regulatory projects
  • Company which empowers people and where your initiatives, and ideas make a real difference
  • International and truly diverse organization
  • Unique possibility to be trained by our internal expertise in the world of bio based products. We invest in relevant training courses related to your particular discipline
  • Engaged team of employees; we want you to be surrounded by happy colleagues who enjoy coming to work
  • Friendly, informal and supportive culture
  • Flexible, open and collaborative working environment
68

Quality & Regulatory Manager Resume Examples & Samples

  • Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management
  • Review and Approval of designated project documentation in product creation projects
  • Advise to product creation projects concerning the definition and implementation of quality assurance activities
  • Advise upper management with respect to release for delivery of products
  • Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments
  • Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals
  • Participation in and verification off changes to DMR and release orders where Q&R involvement is needed
  • Participates in the maintenance and improvement of the Quality Management System
  • Drive the execution of and/or support and advice the organization in corrective and preventive actions
  • Initiate, stimulate, support the implementation of process improvements
69

Regulatory Manager Resume Examples & Samples

  • Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required; OR
  • Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 3 years' research study or other relevant experience
  • Supervisory or project management experience required
  • Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years
  • Strong organization and interpersonal skills
  • Computer expertise include being literate in Microsoft Office, Internet and database use
  • Nursing degree, Master’s or other graduate level degree or the equivalent of education, training and experience from which comparable skills can be acquired
  • Lean/Six Sigma trained
  • Project Management or Program Development experience
70

Regulatory Manager Resume Examples & Samples

  • Formal Trading Standards qualification e.g DTS, DCATS, DCA or equivalent
  • Expert knowledge of legislation and best practice guidelines relating to fair trading, advertising, food composition and labelling
  • Knowledge of legal procedural legislation and guidance
  • Proven expertise liaising with regulators, government and independent bodies (including the Advertising Standards Authority)
  • Lead Assessor qualification beneficial
  • Significant leadership skills
71

Environmental & Regulatory Manager Resume Examples & Samples

  • Bachelor’s degree required. Degree in environmental, chemical, mechanical or process engineering preferred. Degrees in science or environmental studies considered with appropriate experience, skills and knowledge, such as an advanced degree in a pertinent discipline. Seven to ten years of experience required
  • Must have working knowledge of US Federal environmental regulations; international experience a plus
  • Knowledge of management systems such as ISO 14001, OSHAS 18001 or EPA’s CFEMS a plus
  • Must have experience conducting audits, inspections, and evaluations. Lead auditor experience a plus
  • Excellent project management and written and verbal communication skills
  • Consumer Goods industry and/or product development experience a plus
  • Requires 30-40% travel, including international
  • Must be adept in the use of the Microsoft Office suite
72

FTU Regulatory Manager Resume Examples & Samples

  • Education: Master’ Degree/CA/MBA
  • Experience: Candidates with1- 2 years of related work experience
  • Excellent interpersonal/communication skills and ability to develop strong partnerships with clients and other stakeholders
  • Experience of working with FEMA related processes
  • Sound understanding of Capital Markets in India and keeping abreast of emerging market developments
  • Ability to translate complex market requirements through clear and precise verbal and written communication
  • Ability to translate client requirements and work with internal operations team to achieve results to the satisfaction of clients
  • Ability to adapt to constant changing needs of the business
  • Postgraduate qualifications are necessary
  • Excellent MS Excel and PowerPoint skills are an added plus point
73

Global Regulatory Manager, Immuno Resume Examples & Samples

  • In conjunction with Regulatory Leads, coordinate creation and approval of global regulatory plans, and transmit to internal and external experts to execute the plan
  • Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
  • Manage, track, review regulatory deliverables from external partners in line with vendor manager
  • Maintain regulatory work schedules with vendors and vendor managers for assigned project using common data-points and milestones
  • Coordinate GRS support for HA interactions lead by regional / local liaisons
  • Support Regulatory Lead is the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc)
  • Provide support for tracking progress and resolving issues with CTA preparations and submissions and approvals
  • Facilitate the regulatory dossier submissions to HA (IND, CTA, BLA, NDA, etc) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions
  • Coordinate preparation of response to HA questions according to a rapid response process for assigned projects
  • Maintain tracking data in PMC and PMR database
  • Coordinate regulatory communications required for regulatory actions to regional and local regulatory
  • Writing, reviewing signing and submission of maintenance regulatory documents for all IND/CTAs - All within group with consultation of the USL, EUL or GRTL as needed
  • Annual Reporting Responsibilities for regulatory owned components
  • Support submission of US BLA/NDA submissions, as assigned
  • Working knowledge of regulatory procedures (US or other) or in a specific therapeutic area (2-3 years)
  • Demonstrates a high-level of self-motivation and professional commitment. (In)direct management experience of people or major projects
  • Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary)
  • Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills
  • Comprehensive understanding of the pharmaceutical industry
  • Comfortable working in a fast-paced environment where speed is paramount
  • Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions
  • Willingness and ability to effectively cooperate and partner with external vendors and BMS
  • Develop understanding of different TAs due to assignment to different projects
  • Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape
  • Increased exposure to global and multifunctional teams
  • Potential development into Global Strategy function, US Liaison or other role in Regulatory Sciences
74

CMC Regulatory Manager Resume Examples & Samples

  • Directly manage completion of multiple dossier components to meet project timelines
  • Review documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed
  • Accountable for ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements
  • Work closely with project team members and CMC regulatory team to produce high quality submissions
  • Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes. Effectively adjust plans to deal with changes and obstacles
  • Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions
  • Organize and archive CMC dossier components and supporting documents in appropriate document management systems
  • Interface with regulatory operations staff to coordinate dossier review, approval and publishing activities
75

Regulatory Manager Americas Resume Examples & Samples

  • Manages supervisors and manages enterprise regulatory associates located in the Americas region
  • Supports the management of distributor relationships in the regions
  • Requires proven skills in leading/managing the execution of processes, projects and tactics. Knowledge in product regulations required including WEEE, REACH, RoHS, equipment safety directives and similar
76

Regulatory Manager Resume Examples & Samples

  • Plan, provide strategic guidance, coordinate and manage the day-to-day CFDA pre-market approval submissions for Companion Diagnostics (CDx) Including type testing, registration files, instrument clinical evaluation report, IVD local concordance study,and obtain approval of premarket product registration timely
  • University degree in a technical discipline (bio-engineering, chemical, biology, laboratory diagnosis, pharmaceutical preferred)
  • A minimum of 6 years of RA experience in IVD or medical device field
  • Strong skills in regulatory strategy and planning, preferably within vitro diagnostics
  • Experience working directly with CFDA
  • Strong decision-making and leadership skills
  • Experience working in projects as part of project teams
  • Capability of working in multiple project teams in parallel and a sense-of-urgency in meeting deliverables and project requirements
  • Knowledge of pathology and/or oncology is preferred
  • Knowledge and experience in APAC region regulatory affairs is required
77

Regional Product Stewardship & Regulatory Manager Resume Examples & Samples

  • Implement our corporate standards across the business segments and manufacturing facilities in their region
  • Provide functional guidance to the Product Stewardship Coordinators of the business segments
  • Interact with functional groups in the region to ensure alignment on standardized processes
  • Understand and execute ACC’s Responsible Care Product Safety Code Requirements as part of Axalta’s global strategy to obtain and maintain RC 14001 certification
  • Be an active member of the Global Leadership Team for EHS&S and PS&R
  • Lead the Regional PS&R Network
  • Provide guidance to the appropriate functions on how new standards/legislation will impact our business operations and our overall strategy for PS&R
  • Responsible for the auditing schedule and process to confirm our performance and compliance against program metrics and goals, internal company requirements, and regulations in an effort to drive continual improvement
  • Develop leading and lagging indicators to track performance and understand trends to improve
  • Stay abreast of regional, social and regulatory trends and impending actions that may have an impact on company, products, process and markets and advise regional leadership
  • Provide key insights into corporate advocacy objectives and strategies
  • Lead efforts to identify and implement consistent best practices from the standpoint of effective and efficient tools, as well as standardized practices and processes
  • Report on established, key metrics to evaluate the program’s performance related to addressing product risks, program alignment with other business functions, regulatory and customer requirements
  • Ensure necessary information systems and tools are in place and maintained to meet requirements for Product and Global Chemical Data Management and Reporting
  • Responsible for investigating and reporting of Product Stewardship Incidents to identify and analyze root cause, as well as communicating to raise awareness
  • Effective change management skills and demonstrated ability to lead and inspire positive change within an organization
  • Highly proficient relationship management and networking skills
  • Proven ability to influence, negotiate, and resolve conflicts
  • Experience in working with cross-functional, multi-cultural, and virtual teams
78

Regulatory Manager Resume Examples & Samples

  • University Graduate in pharmacist or science, post graduate would be an advantage
  • English Language – written and spoken fluently
  • Bahasa Indonesia - written and spoken fluently
  • Must be able to communicate clearly and concisely in both languages
  • Min 5 years of experience in regulatory position with a reputed Consumer Health Company with working experience in managing registration for Cosmetics or Skincare products
  • Experiencing in changing regulatory environment i.e. proposing the change of regulatory system/regulation
  • Had been exposed to quality, production & R&D environment
  • Strong logical and technical skills
  • Mastering the Indonesia registration regulation and its related regulation
  • Having a good relationship with government official and associations
  • Bridging the external and internal requirement
  • Knowledgeable in quality system and product development system
79

Regulatory Manager Resume Examples & Samples

  • Develop and implement robust regulatory strategies to support portfolio of assigned active sub-stances and products in EAME
  • Provide high quality regulatory advice and foresight to wider EAME Regulatory and key stake-holders (e.g. business, development, global) to support the development of EAME portfolio strategy
  • Provide regulatory insights into competitor portfolios to wider EAME Regulatory and key stake-holders (e.g. business, development, global) to support the development of EAME portfolio strategy
  • Obtain and maintain EU approval of active substances in line with agreed portfolio objectives through
  • Good understanding of regulatory processes in the EU
  • Regulatory experience in the EU
  • Effective time and task management to ensure delivery of the business needs
  • Delivery of quality work even under time pressure
  • Ability to manage complex issues without being the expert in any one discipline
  • Openness and willingness to challenge the accepted ways of working and to implement new ones
  • Active management of the workload
  • Willingness to try new approaches
80

Regulatory Manager Resume Examples & Samples

  • Total package up to £72k (depending on experience)
  • Establishing the ‘missing market(s)’ for flexibility services in electricity
  • Participation in the related Ofgem Flexibility project
  • Electricity Balancing markets
  • Commercial opportunities for energy storage
  • Developing the roles and responsibilities of electricity network system operators (transmission, distribution), including their interfaces with the commercial market
  • An excellent understanding of power generation, wholesale electricity markets, decentralised energy and the policy framework within which commercial companies, relevant industry bodies and network companies operate
  • Regulatory experience in the power & electricity markets with high quality strategic, technical, economics or legal qualifications
  • Good understanding of the regulatory frameworks within which Centrica Group operates, and of the regulatory decision making processes
  • An proven ability to “horizon scan”: anticipating and keeping abreast of external developments that may influence the direction of electricity policy and / or create new business opportunities
  • Proven experience to develop innovative and powerful solutions to complex regulatory proposals driving value or avoiding cost
  • Ability to work flexibly, across a wide range of high profile and fast moving tactical and strategic issues
  • Strong leadership skills and a proven track record in influencing to deliver commercial value
  • Excellent verbal, presentation and reasoning skills
  • Ability to build constructive relationships at all levels of an organisation
  • Excellent analytical and conceptual thinking skills
81

CMC Regulatory Manager Resume Examples & Samples

  • BSc in life sciences or equivalent qualification/expeirence
  • CMC Regulatory Affairs or CMC development experience in Biopharmaceuticals or Cell & Gene Therapy gained with direct involvement in regulatory submission preparation
  • Experience of authoring or preparing and submitting CMC content for clinical trial applications and/or marketing applications
  • Strong verbal and written communication skills with good attention to detail
  • Capable of working and making decisions independently
  • Successful track record of delivering CMC strategies and submissions content that comply with global regulatory requirements
  • Excellent team working abilities and effective influencing skills
  • Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
  • Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives
  • Represent Biopharmaceutical CMC Regulatory Affairs on regulatory networks and matrix teams, providing regulatory advice and guidance to product development teams and the global manufacturing organisation
  • Be responsible for the global CMC regulatory activities for projects teams, setting the strategy for CMC regulatory content of clinical trial applications and marketing applications
  • Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of Biopharmaceutical and/or Cell & Gene Therapy products
  • Support license maintenance, change control requests, and post-approval submissions, ensuring delivery to agreed timelines
  • Maintain high quality standards and a continuous improvement and innovative approach in responding to the evolving regulatory environment
  • Communicates across the company to influence CMC project and policy issues that are aligned with business needs
  • Based in Ware, Hertfordshire, UK this role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity
82

Regulatory Manager Resume Examples & Samples

  • Master of Science (M.Sc, field of food chemistry/biotechnology or similar) or a Master of Laws (LL.M.)
  • Min. 3 years functional technical experience within food regulation, mainly EU
  • Experience within production or Quality from European food industry or experience from Food Authorities
  • Knowledge of beer, cider and other beverages and their production
  • A team-player, who promotes collaborations across functions with colleagues and customers of diverse background and culture
  • Works independently, systematic and detailed with known as well as new subjects
  • Excellent at multitasking and prioritizing as appropriate
  • Ccredible and accountable and demonstrates commitment and personal ownership
  • Makes problems clear so that they can be tackled
  • Plans effectively, sets priorities and puts ideas into practice
  • Develops, shares and utilizes best practice
  • Preferable knowledge of web based applications (MS Sharepoint)
83

Regulatory Manager Resume Examples & Samples

  • In collaboration with Sandoz Development and Maintenance Centers, the RCC-Manager is accountable for the preparation and coordination of regulatory submissions for assigned countries, ensuring each molecule has a defined regulatory strategy and in full compliance with government regulations
  • In collaboration with Sandoz Licensing Regulatory Department and Country Organizations, is responsible for new product assessments and due-diligence activities with local and international partners
  • Responsible for analyzing the dossier for any gaps for predicted DLs from the authorities and to put the strategy for them (GAP Analysis)
  • Accountable for the timely approval and the regulatory launch readiness of Sandoz products in the territory
  • Monitor and evaluate changes in local and regional regulations for regulatory impact on development projects and ensures commercial feasibility of regulatory strategy
  • Manage internal and external regulatory inquires and response strategy for deficiency letters in close collaboration with country organizations
  • Participate in the development and implementation of local and regional regulatory strategy with Sandoz Development & Maintenance Centers and international partners. Acts as primary technical & regional expert for assigned countries and projects
  • Participate in local and regional meetings, lead and represent Sandoz in external meetings and conferences (as required)
  • Mentor and assist junior associates
84

Global Program Regulatory Manager Resume Examples & Samples

  • Responsible for implementing regulatory strategy and managing operational activities for assigned regions
  • Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions
  • Partners with regions to align on regulatory strategy in order to fullfill business objectives. - Implements RFP across assigned regions
  • Works with DRA GPT representative and/or GTAL to plan and facilitate presentations to Novartis regulatory boards on regulatory strategy
  • Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders
  • Works with DRA GPT representative and/or GTAL to interact with regulatory consultants/advisors for strategy input and challenge
  • Represents DRA on or leads sub-teams as required. HA Interactions
  • Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL
  • Interacts directly with HAs as appropriate in meetings with DRA GPT representative and/or GTAL
  • Coordinates and plans rehearsals for HA meetings
  • Facilitates preparation and finalization of briefing books
  • Develops and implements plans for timely response to HA requests and coordinates responses
  • May serve as local HA liaison depending on location (e.g., FDA or EMA)
  • Experience with regulatory submission and approval processes in 1 or more major regions
  • 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas
  • Regulatory operational expertise. - Strong interpersonal, communication, negotiation and problem solving skills. - Basic organizational awareness (e.g., interrelationship of departments, business priorities)
85

Financial Services Africa Banking Regulatory Manager Resume Examples & Samples

  • Manage the delivery of Advisory engagements
  • Assist in managing the financial aspects of engagements by organising staffing, tracking fees and communicating issues to project leaders
  • Build strong internal relationships within Financial Services Africa and across other services
  • Supporting and guiding clients to meet regulatory requirements for reporting and business standards
  • Reporting to clients and SARB
  • Client liaison, including leading meetings with clients and the SARB
  • Build strong and long term relationships with key client sponsors
  • Contribute to people initiatives including recruiting, retaining and training Financial Services Africa professionals
  • Develop personal profile and awareness of EY offerings in the marketplace
  • Manage risk of delivery on client engagements
  • Act as an ambassador of EY in the market and with clients
  • Thorough knowledge of banking regulatory reporting and related processes
  • Four years to eight years of relevant work experience preferred
  • Ability to understand and adapt to changing regulatory and legislative requirements
  • Extensive knowledge on
  • Track record with a blue chip risk consulting firm or large banking institution
  • Relevant postgraduate degree with strong academic record
  • Professional qualification such as CFA, FRM, PRM preferable
86

Regulatory Manager Resume Examples & Samples

  • BS degree in business or science discipline
  • 5+ years’ recent team management within a business environment
  • EPA/FDA industry experience preferred with a functional knowledge working with regulated products
  • Must be able to interact effectively with internal and external customers to meet timelines
  • Attention to detail/documentation and excellent written and oral communication skills
  • Must be able to work in a multi-task environment
  • Proficient with MS Office Suite is required
  • Domestic travel estimated <10% or as business needs determines
87

Regulatory Manager Resume Examples & Samples

  • Monitor and participate in the stakeholder processes for the Electric Reliability Council of Texas and Southwest Power Pool. This will involve providing the trading and marketing groups with information about rule changes and other developments that will impact company positions or operations or the markets in which Shell Energy participates, advocating positions in these processes that will protect or advance the company's objectives and provide advice on potential market or operational outcomes
  • Follow developments before legislative bodies, state utility commissions (with focus on Texas PUC) the Federal Energy Regulatory Commission and other governmental agencies that may affect gas and power marketing and trading activities in the region and report on such developments to relevant groups within the company
  • Provide support for the company's marketing and trading activities, including tariff review, commenting n transactional documents and acting as a compliance resource relating to such activities
  • Manage participation in regulatory proceedings through the filing of pleadings or directing the activities of outside counsel
  • Represent the company in trade associations and work with such organizations or ad hoc advocacy groups before regulatory and governmental bodies to advance the company's objectives
  • Support the efforts of other professionals within the Regulatory Group and assist other Shell entities on relevant issues
  • Support the development of new commercial products, strategies, or efforts with interpretation and implementation of ISO/RTO policies
  • Maintain relationships with each RTO/ISO, and potentially commercial customers, to support various commercial needs, including, but not limited to, operation of congestion revenue rights/transmission congestion rights markets, energy markets, capacity markets, and policies pertaining to traditional grid-switchable resources
  • Act as liaison with customers, ISO/RTOs, NERC/PUC entities, and Shell commercial teams to verify compliance with regulations as they pertain to Shell
  • Manage and provide feedback and support to contract resources providing regulatory intelligence to Shell
  • Maintain a fundamental understanding of wholesale electric power markets
88

Regulatory Manager, North Asia Resume Examples & Samples

  • Bachelor degree or above in Chemistry, Applied chemistry or strong technical related background
  • Have in-depth knowledge of paints related industry
  • Has a proven track record of managing projects in cross-functional environment in multinational company
  • Experience in PSRA or HSE is required, Green label accreditation or business Regulatory Affair experience is preferred
  • Be skilled in English and be capable to interact with senior colleagues across the globe with ease
  • Has strong commercial sense to be able to interpret regulation requirement with Business team
  • Good communication skill and influencing skill
89

Global Payments Product Risk & Regulatory Manager Resume Examples & Samples

  • Deep Industry knowledge of Payment systems
  • Broad understanding of current regulatory environment
  • Analytical individual with ability to model data and draw conclusions
  • Graduate Degree, with distinguished academic achievement, high level of personal integrity, interest in banking as evidenced by related work experience, proven dedication to excellence, leadership qualities and a flexible, creative, innovative personality
  • Technological proficiency, Analytical and modeling proficiency, excellent excel, presentation and writing skills
90

Regulatory Manager, Americas Resume Examples & Samples

  • Develops, implements solutions to department and enterprise global issues and regulations
  • Bachelor's or Master's Degree preferably in engineering or scientific discipline or equivalent combination of education and experience
  • 7+ years of relevant regulatory experience with 2+ years as a manager
  • Proven skills in leading/managing the execution of processes, projects and tactics
  • Knowledge in product regulations required including WEEE, REACH, RoHS, equipment safety directives and similar
91

RN Accreditation & Regulatory Manager Days Quality Resume Examples & Samples

  • Current CA RN license with a minimum of 8 years of experience in acute hospital setting
  • Bachelor’s degree required, preferably in a health-related field
  • Experience in facilitating regulatory surveys and surveyor visits for Joint Commission, California Department of Public Health, and Centers for Medicare and Medicaid
  • Experience in providing education, team facilitation and coaching
  • Excellent interpersonal, communication skills and presentation skills
92

Regulatory Manager for Corporate Office Resume Examples & Samples

  • A university degree in economics or law with a focus on banking
  • Experience within the financial industry in a central and governing function
  • Knowledge around EU/EBA regulations
  • Experience within a matrix function
  • A good understanding for the financial industry and its challenges
  • An analytical focus
  • A "can do" mentality
  • Stamina and robustness
  • A pro-active mindset and works self-guided through agreed priorities
  • Good communication skills and is able to orchestrate a variety of stakeholders
  • A strong team playing attitude
  • A diligent way of working and is reliable and can deal with confidential information in a compliant manner
  • Fluent English proficiency and is ideally able to speak either German/Italian or Spanish
  • Excellent MS-Office skills, especially in Excel and Powerpoint
93

Regulatory Manager Resume Examples & Samples

  • Implement R&D projects and achieve registration milestones
  • Support the preparation and submission of national registration dossiers
  • Serves as the interface between the Commercial, Marketing and the Research & Development Organizations
  • Provides regulatory and policy consultant of existing products sales and marketing teams as well as customers
  • A minimum of a Master Degree in Biotechnology, Life Sciences, Plant Protection or related areas (Ph.D. degree in the above areas is a plus)
  • Experience in pesticide and Biotech product registration
  • Excellent leadership
  • A great team player
  • Self-motivated, initiative and innovative, independent and hard working
94

Compliance Regulatory Manager Resume Examples & Samples

  • Act as Company coordinator for market conduct examinations of Cigna companies. Serve as liaison to insurance department examiners during the examination process
  • Assess market conduct issues and findings, communicate company position statements, develop appropriate responses and corrective actions, and negotiate outcomes to mitigate risk for the Cigna companies
  • Identify compliance gaps and work collaboratively with business partners regarding corrective actions
  • Communicate overall strategic direction to business partners relative to market conduct and practices
  • Complete all pre-examination surveys, data requirements and examination materials in an accurate and timely manner
  • Provide responses to examiner requests and criticisms within stated/negotiated timeframes
  • Utilize internal tracking tools, as appropriate, to document market conduct activities
  • Act as an advisor/consultant to business partners regarding regulatory examinations
  • Assist in the development of practices to address issues and to close compliance gaps and mitigate risk for the Cigna companies
  • Develop business partner relationships to assist in fostering a compliance environment throughout Cigna with mutual ownership
  • May represent Cigna on regulatory and industry committees and projects
  • Candidate must have previous experience working directly with Departments of Insurance, preferably with health care products. Minimum 5-8 years of compliance/regulatory experience is a must
  • Typically requires Bachelor’s or equivalent training and mastery; or any combination of education and experience
  • Master’s or JD degree preferred
  • Knowledge of Cigna products, systems and processes preferred
  • Strong knowledge of insurance, healthcare, legal, government/regulatory environment to understand and articulate compliance barriers and suggest compliant alternatives
  • Superior verbal/written communication and interpersonal skills required
  • Excellent time management skills with ability to multi-task in deadline driven environment with competing priorities
  • Ability to work and make decisions independently
  • Results oriented with ability and willingness to work in matrix environment
95

DRC Research Regulatory Manager Resume Examples & Samples

  • Experience in the administration of an Institutional Review Board
  • Outstanding written, verbal, interpersonal and organizational skills
  • Familiarity with PC applications, medical terminology, research design, statistics and academic and regulatory functions
  • Dedication to providing service
  • Ability to foster positive relations with multiple, diverse constituencies to influence and shape change
  • Strong customer focus (ability to listen attentively to residents/fellows and faculty and to understand and respond positively to their requests)
  • Ability to work under pressure, with the flexibility to respond to changing priorities and fluctuating workloads
  • Physical ability to move large bundles of paper and heavy boxes of paper
  • Certified IRB Professional designation preferred
96

Senior Regulatory Manager Resume Examples & Samples

  • As this role is strategically aligned with the operational and regulatory goals for SCE, Regulatory Affairs, and Customer Service, the Senior Regulatory Manager will frequently and proactively interact with senior and executive SCE and CS management as well as external regulatory representatives
  • Provide regulatory leadership, motivation, direction and management of a team of project managers and business analysts as well as cross-functional teams for the GRC and IQP and other CS-related major regulatory proceedings
  • Manage the development and processing of CS participation in major regulatory proceedings through frequent contact with key subject matter experts in CS and with other OUs
  • Manage cross-functional teams to develop supporting policy position for testimony, responding to discovery requests, and addressing ad hoc regulatory analytical projects based on executive CS management requests
  • Manage the development and implementation of regulatory policies and strategies to support participation in GRC and IQP regulatory proceedings
  • Manage the development of regulatory input and assessment for the corporate strategic planning process
  • Create and implement framework to identify strategies and tactics to accomplish goals and objectives of the GRC and IQP proceedings
  • Provide leadership, motivation and management direction to in regulatory proceedings
  • Timely and high quality execution while meeting executive leadership expectations on deliverables
  • Develop workforce capabilities by managing employee performance and development by conducting performance planning and reviews, coaching employees, and carrying out disciplinary action when necessary
  • Create a work environment which promotes working collaboratively by promoting effective teamwork between direct reports and across departments
  • Motivate best performance through continuous engagement and dialogue with a focus on problem-solving identified elements that distract achievement of the highest quality performance
  • Represent the company to various external organizations including electrical associates/affiliates, customer advocacy groups, manufacturers, other utilities, various governmental bodies, regulatory agencies and community/civic groups
  • Bachelor’s Degree in Business, Public Policy, Public Administration, Economics, Engineering, or related field
  • Must have four or more years’ experience in project management of cross functional teams or similar cross-functional coordination, and/or strategic planning, and/or energy markets, and/or regulatory policy development
  • Must have experience analyzing and interpreting energy related regulations, legislation or policies
  • Experience managing teams or cross functional teams developing regulatory documents such as Applications, Advice Letters, Direct and Rebuttal Testimony, and Comments
  • Typically possesses seven or more years of experience in regulatory affairs, operational programs, contact management, or function being managed plus seven or more years of supervisory or project management experience
  • Electric utility industry experience
  • Demonstrated knowledge of state and federal regulatory and/or legislative functions and processes
  • Customer focused to understand and respond appropriately to clients' business needs
  • Demonstrated ability to take initiative, be accountable for individual results, and motivate self and others to set and achieve high performance standards
  • Demonstrated strong organizational skills with high level of initiative and ability to effectively interface, collaborate, and partner with stakeholders, senior management, clients and team members to help drive solutions and ensure stakeholder buy-in
  • Proficient with Microsoft Word, Excel, PowerPoint, Project, and Visio
  • Ability to follow Edison safety protocols and safe work practices
  • Must demonstrate effective decision making, results delivery, team building, and the ability to stay current with relevant technology and innovation
97

Regulatory Manager Resume Examples & Samples

  • Understand and communicate relevant regulatory trends impacting Innovation and Renovation
  • Provide and manage regulatory and scientific input to confectionery product and process development
  • Provide regulatory advice to our Operating Companies and Nestlé HQ
  • Share regulatory knowledge through networks and provision of training
  • Support the development of advocacy plans to support business growth
98

China Trade Compliance Regulatory Manager Resume Examples & Samples

  • Strong knowledge of general China Customs and import/export laws and regulations, and China Customs policies and procedures
  • Familiar with China Customs organization, hierarchy, internal and external working mechanism
  • Diplomatic communication with government officers to address the case clearly with focus
  • Strong business sense with excellent trade-off in working
  • 8+ years of experience in trade agencies or associations, or similar experience with strong expertise and background in trade compliance
  • A mix of compliance and program management experience
  • Excellent interpersonal skills enabling communication with professionals and people in various levels, and to operate effectively within a team environment
  • Experience in developing and implementing cross functional processes and procedures
  • Experience leveraging technology and data mining to drive process improvements
  • Working experience in trade agencies with senior or medium level rank
  • Ability to work on multiple concurrent tasks and projects
99

Quality Systems & Regulatory Manager Resume Examples & Samples

  • FDA/cGMP Compliance
  • Interpret Existing or New Regulatory Requirements as they Relate to Company Products/Operations and Procedures, Testing, Records, Etc. to Ensure Ongoing Compliance
  • Provide Regulatory Guidance and Support to the Organization Including Regulatory Filing Strategies, Policies, Procedures and Standards Requirements
  • Review, Provide Feedback and Approve Process and Manufacturing Changes, Non-Conforming Materials, Test Protocols and Reports Ensuring Regulatory Compliance with FDA/cGMP and Other Applicable Standards
  • Conduct Internal Audits of QC Lab, Operations, Manufacturing, Labeling, Etc., and External Suppliers
  • Represent the Company with External Regulatory Officials Including Onsite Visits and Written Communications
  • Initiate and Implement CA/PAs Identifying and Addressing Findings, Issues and Non-Compliances
  • Investigate Product-Related Customer Complaints as Pertains to cGMP Compliance and Manage the CA/PA Process
  • Assure Quality and Manufacturing Processes Comply With cGMP and Other Regulatory and Industry Standards
  • Author and Update SOPs
  • Lead and/or Support Investigations into Variances, Non-Conformances, Complaints and Quality Issues Assuring Proper and Enduring Changes are Made
  • Ensure All Manufacturing and Packaging are In-Compliance with Manufacturing Directions
  • Produce Weekly and Monthly Reporting Package with Relevant Metrics and Goals for Quality Processes
  • Create Documented Processes for Major Functions and Ensure Employees Are Following Processes
  • Support Company Initiatives, Especially the Company’s 123SQP Plan
  • Lead the Company’s Recall Program Including Lot Traceability and Mock Recalls
100

Product Regulatory Manager Resume Examples & Samples

  • Managing a global registration project including meeting milestones, identifying risk, and communication with regional regulatory authorities, and local and global sales and marketing teams on timelines
  • Maintaining most up-to-date information in regards to government legislation as it relates to regulatory or scientific affairs
  • Contributing to global product planning and launch teams to ensure timely product introduction by providing regulatory support and recommendations for new products
  • Bachelor's degree, preferably in a science major
  • 5+ years of Regulatory Affairs experience
  • Prior experience with pharmaceuticals, natural medicines, or dietary supplements preferred
  • Strategic thinker, with forward planning and project management skills
  • Will consider candidates with a senior sales/business development background in the following arenas; pharma, nutraceuticals, ingredients, who would be open to taking on the Regulatory aspects of this position
101

Human Research Protection Regulatory Manager Resume Examples & Samples

  • Under government guidance, the contractor is responsible for the operation and management of the Regulatory Affairs and Research Compliance program
  • Ensures compliance of research programs with applicable sponsor, local, state and federal regulations for human subject research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA)
  • Assists in the development and updating of the DVBIC regulatory compliance policies, standard operating procedures, requirements and related matters
  • Establishes training programs in human subject protection and HIPAA compliance
  • Conducts research compliance monitoring
  • Obtains Scientific review of proposals and protocols
  • Facilitate information flow and acts as liaison between agencies such as USUHS, Federal and Contractor Principal Investigators and research staff, administrative staff, Institutional Review Boards (IRBs), Institutional Animal Care and Use Committees (IACUCs) Institutional Bio-safety Committees (IBCs), research administration offices, Food and Drug Administration (FDA), Office of Human ResearchProtections (OHRP)
  • May conduct site monitoring visits to ensure compliance with regulations and human subjects protection
  • May encounter patients who are confused, agitated, or abusive
  • Minimum 5 years related experience in clinical program management and 10 years’ experience in clinical research and/or regulatory affairs arena required
  • The contractor will normally work up to 40 hours a week, 0800 to 1630, Monday through Friday (hours may vary)
  • Must be available to travel locally, regionally and nationally
102

Regulatory Manager Resume Examples & Samples

  • Leading, and being a core contributing member of multi-disciplinary teams across Centrica developing and agreeing our strategic response to Ofgem investigations relating to energy regulation, combining commercial, Legal and Ethics & Compliance team resource and external advisers as appropriate
  • Leading on the preparation of submissions to Ofgem relating to energy investigations, and stakeholder meetings on related subjects
  • Management of key relationships within Ofgem relating to regulatory investigations
103

Quality / Regulatory Manager Resume Examples & Samples

  • Responsible to create and implement organizational standards and procedures to comply with applicable regulations
  • Responsible for developing and maintaining relationships, as necessary with regulatory agencies, customers or supplier quality representatives
  • Keep informed regarding pending regulatory changes, trends, and best practices and assess the potential impact of these changes on organizational processes
  • Manages non-conforming material’s review board (MRB) system including WIP rejects and incoming materials
  • Support operations management in assessing material and process defects in support of corrective action programs
  • In conjunction with the Materials function, actively and continuously pursue improvements in supplier quality, OTD, auditing, and supplier corrective actions
  • Interface with multiple departments, levels of management, customers and Suppliers
  • Complete and disseminate quality metric reports
  • Maintain ISO certification, perform audits and work with auditors to improve processes
  • Will travel up to 25% to customer and vendor sites
  • Lead special projects as assigned
  • Support the Management of Daily Improvement (MDI)
  • Responsible for the overall management of the Quality/Regulatory Department, including staff supervision
  • Bachelor’s degree in Engineering or other technical discipline preferred
  • 10+ years of progressive experience in Quality Assurance/Regulatory Compliance and a minimum of five years management/supervisory experience in a Quality/Regulatory role
  • Comprehensive knowledge of quality assurance practices and processes
  • Excellent knowledge of ISO 9001 and 13485
  • Internal auditor and continuous improvement experience required
  • Excellent written/verbal/teaching skills with attention-to-detail
  • Demonstrated PC, Microsoft Word, Excel and Access database skills
  • Experience or trained in Six Sigma methodologies, TQM, Lean fundamentals preferred
  • Must have a working knowledge of quality programs, with experience in a variety of measuring/inspection instruments, auditing processes and closed loop corrective action programs
  • Formal experience and training in multi-disciplined project/program management required
  • Ability to work in both a team environment and autonomously
  • Excellent listening skills and attention to detail
  • Multi-task oriented with ability to manage multiple projects and ensure goals and timelines are met
  • Maintain composure and professional approach when dealing with public
  • Ability to make decisions logically
  • Capable of focusing on details with regard to procedures and workflow
104

Regulatory Manager for India Resume Examples & Samples

  • Member of the global MPP regulatory & standards core team
  • Responsible for the regulatory & standards strategy for MPP in India and supporting R&S activities in ASEAN countries
  • Responsible for effective relationship management with Targeted Regulators, Professional Influencers and Thought Leaders in the broader industry and its stakeholders
  • Participation & Leadership in targeted standard setting organizations, in particular with Bureau of Indian Standardization (BIS)
  • Participation & Leadership in targeted industry associations
  • Support the demand creation through influence and education with key government agencies and influential industry associations for medical device and pharma manufacturers as well as hospitals in India
  • Support and provide training to local DPS organizations in identified AP regional countries (ASEAN) on regulatory topics, strategy and key activities for local regulatory engagements
  • Develop a regulatory map & knowledge base to identify key regulatory issues, stakeholders, activities and events for India and AP regional countries
  • Establish key milestones and measurements of success for regulatory influence work streams and ensure the progress is on track
  • Support other functions (such as quality, technical) to provide regional regulatory guidance
  • Support the MPP SPM account management process
  • Support the MPP MDM outreach and key account management processes
  • Support the MPP Healthcare Outreach& Thought Leadership Initiatives
  • 8 - 10 years of experience in dealing with medical and/or pharmaceutical regulatory issues. Experience in the development of standards is an asset. Knowledge of sterilization and packaging standards is an asset
105

Regulatory Manager Carbone Cancer Center Resume Examples & Samples

  • Minimum 4 years of clinical research and/or regulatory experience required, oncology experience preferred
  • Prior experience with Institutional Review Board (IRB) application process required, 3 or more years preferred
  • Respect: Demonstrate respect for self and others--behave professionally
  • Integrity: Act with integrity and honesty
  • Teamwork: Commit to and demonstrate teamwork
  • Excellence: Ensure excellence, quality, and high ethical standards in conduct and performance
106

Regulatory Manager, Flavors Group Resume Examples & Samples

  • Supports internal customers (including Customer Service, Sales, Research & Development, Quality Assurance) by serving as subject matter expert in assigned areas by interpreting regulations, providing information to address external customer needs, providing guidance in the development of products to internal customers, and by accurately maintaining product information databases
  • Supports external customer by providing routine or standard technical information in areas of subject matter expertise / core technology. Serves as the primary resource for non-routine or confidential information disclosure
  • Provides explanation of compliance strategies for Sensient Technologies products and discussion of product and compliance options. Provides information on and responds to requests regarding emerging issues, impact of proposed regulations and possible applications of Sensient Technologies products and labels
  • Propose new procedures or adjust existing ones when necessary. Adheres to regulatory procedures to assure compliance to Sensient Technologies. compliance policies
  • Utilizes authorized Sensient Technologies systems for maximum efficiency and consistency. Places responsibility for compliance with function closest to customer or agency for maximum efficiency and accountability
  • Audits adherence to policies and procedures as directed; recommends corrective actions(s); follows up to ensure that appropriate actions have been taken to achieve compliance
  • Establishes and maintains expertise in of the principles set forth in the food regulations for assigned core technologies, ingredient categories and associated regulatory agencies
  • Tracks, monitors and understand regulations for assigned core technologies and regulatory agencies, and assesses impact on Sensient Technologies business. This can include participation in professional societies and trade associations and contacts with industry colleagues
  • Actively cross-trains with others to relieve high volume issues and maintain a balance of workload within the department
  • Trains and communicates information to appropriate personnel. Actively listens and shares information and knowledge with others in an effective and a timely manner. Ensures that appropriate information is communicated, received and understood
  • Demonstrates the technical/functional skills to fulfill the needs of the role and continually develops expertise. Actively pursues personal development to improve and add skills in order to effectively apply expertise internally and externally
  • Demonstrates the flexibility and ability to adapt to a changing environment
  • Provide external representation of Sensient Technologies. interests with regulators and regulatory agencies and with other authorities and institutions
  • Develops relationships inside and outside the organization to enhance personal and company effectiveness
  • Specific assigned responsibilities with regulators and agencies can include
  • Application for, amending and renewal of permits, registrations and licenses
  • Managing or contributing to audits or inspections
  • Seeking clarification on existing, or commenting on proposed regulations, guidelines or standards
  • Preparing and submitting information for required filings and reports
  • Represents Sensient Technologies. interest in external organizations, including presentation of Sensient Technologies. position on specific issues and topics; or provide knowledge and expertise for representation by others, as requested. Update concerned groups as necessary
  • Drives technical initiatives, with the ability to work across functions
  • Systemic problem solver, implementing solutions to solve root cause problems. Strong analytically
  • Works well within a team structure, has the ability to influence without direct control, can sell ideas and articulate business benefit of functional initiatives
  • Ability to take a stand while working in a team environment
  • A minimum of a Bachelor of Science degree in food science, chemistry or related field
  • 10 years of industry experience in regulatory and/or quality, or similar function required to address compliance with food and beverage regulations
  • Knowledge and understanding of food composition and chemistry is required
  • Ability to judge the applicability of technical information from unrelated sources to issues specific to Sensient Technologies products and raw materials
  • Strong knowledge of local, region, and global federal regulations and government agencies. Extensive knowledge of regional and international food and beverage regulations and their application
  • Industry-specific knowledge of ingredients, food allergens, ingredient functionality and product formulas
  • Computer skills – Word, Excel, PowerPoint, etc. Comfortable managing with facts and data vs. subjectivity
  • Keen attention to detail and precise execution of policy
  • Ability to develop vendor relationships
  • Demonstrated ability to effectively organize and manage numerous work tasks of a diverse nature
  • Demonstrated ability to review, interpret and apply sometimes vague regulations to complex formulas. Demonstrated ability to review, interpret and summarize technical information(e/g/ laboratory analyses, processing technologies)
  • Strong written, oral and facilitation skills. Ability to maintain communication composure with outside agencies
  • Excellent listener. Empathetic to individuals concerns and directs necessary follow-up actions
  • Conveys information in understandable terms at all levels of the organization
  • Ability to evaluate and communicate risk; communicate details for fact based decision making
  • Personal and social competence
  • High integrity and honesty, promoting trust in all actions
  • A lifelong learner who continues to develop expertise of in the area of regulatory compliance
  • Enjoys working in a results-oriented, customer focused, team environment
  • Works well under pressure situations and tight timelines
  • Primary language English, Secondary language of French, German, Italian or Spanish preferred
  • High energy. Assertive, energetic, and a self-starter
107

Regulatory Manager Resume Examples & Samples

  • Ability to rapidly adapt to different issues and projects at one time
  • Ability to work with multiple priorities
  • Ability to adapt to new priorities
  • Ability to manage several parallel, ongoing activities
  • Cope with strict timelines, urgencies
  • Demonstrates high level of self motivation and professional commitment
  • Solid scientific background (university degree of chemistry, life sciences, pharmacy, medicines, PhD level desired)
  • Good understanding of the pharmaceutical industry and have an understanding of European Centralised Regulatory Procedures
  • 2-3 years of direct (or relevant) hands-on experience in regulatory procedures (preferably)at the European level
  • Industry experience in related function is desired
  • Great communication, organization and attention-to-detail skills
  • Strong team spirit and supporting attitude
108

Benelux Regulatory Manager Resume Examples & Samples

  • Manage legal / RA questions concerning products of ADC
  • Manage questions from local health authorities
  • Manage product documentation
  • Interact with national governmental bodies
  • Interact with European governmental bodies
  • Lead public procurement processes
  • Advising role concerning strategies and regulatory requirement
  • Advising in the interpretation and application of IVD regulations as well as the planning and implementation of new and updated regulations
  • Review advertising and promotional materials for regulatory compliance
  • Strengthen Regulatory Affairs in the DNA of the organization
  • Reporting to the country manager BENELUX
109

Global Regulatory Manager Resume Examples & Samples

  • Work with Global Regulatory, other Deloitte Global groups (i.e. Global Audit, OGC, Risk, Public Policy, the Global CEO’s office, etc.) and member firm leadership to support regulatory programs and initiatives
  • Prepare briefings and support planning activities in conjunction with Global leadership regulatory internal and external interactions
  • Attend meetings with Regulatory leadership, take notes, and provide briefings and other support to execute agreed-upon action items as needed; monitor execution of action items
  • Develop tools, templates, and guidance necessary to support execution of regulatory initiatives
  • Conduct research and summarize the results on key strategic issues in the global regulatory environment
  • Draft communications and resources to educate Deloitte member firms on relevant regulatory matters, as well as to educate specific audiences such as clients, where relevant
  • Provide support on other strategic and/or ad hoc projects
  • Some international travel is expected
  • 3 - 5+ years of working experience in audit or legal; risk management or project management experience is a plus
  • Experience working in a professional services environment strongly preferred
  • Deloitte network experience preferred, but not required
  • Excellent communication and presentation skills, with the ability to translate quantitative and qualitative analyses into clear messages for the audience
  • Strong Microsoft Office suite skills and strong quantitative background are required (strong focus on PowerPoint skills)
  • Comfortable working in a global, matrixed environment
  • Ability to deliver under pressure and provide informed responses to leadership in short timeframes
  • Ability to handle sensitive leadership information with utmost confidentiality
  • Ability to be self-directed and responsive
  • Project management skills and demonstrated experience successfully working within a cross functional and cross-border team
  • Flexibility for limited international travel
110

Regulatory Manager Resume Examples & Samples

  • Establishes the H-E-B Own Brands labeling regulatory guidelines with the Own Brand leadership team
  • Ensures that regulatory strategy for every Own Brand product meets the corporate Own Brand strategy
  • Bachelor's Degree in Language Arts or Communication or related field or comparable experience
  • 10+ years experience in labeling and / or regulatory
  • In-depth knowledge of product and food labeling (USDA, FDA, FTC and NAFTA)
  • In-depth knowledge of Standard Operating Procedures of federal regulatory entities (USDA, FDA)
  • Minimum of three years of prior management experience
  • Proficient in Microsoft Office Suite-- Word, Excel and PowerPoint
  • Knowledge of Mexican packaging/labeling laws (NAFTA)
111

Product Stewardship & Regulatory Manager Resume Examples & Samples

  • Provide global strategic feed innovation & approvals coordination and advocacy support across industries and regions
  • Collaborate with individuals at varying company levels with global coordination focus
  • Coordination of global regulatory compliance for marketed IB products touching the feed industry, in conjunction with regional regulatory staff and product management supporting food industries
  • Global focus on key trade associations across all regions; work with regional team leads on key DuPont IB animal feed & health issues to ensure globally aligned positions
  • Identify and communicate changes in policy; coordinate global efforts across regions to influence national regulations in areas related to the Bioactives feed business through strong advocacy and leadership
  • In depth knowledge and recognized for leadership & innovation in managing animal feed and/or animal health regulatory or similar program
112

Internal Audit Senior Regulatory Manager Resume Examples & Samples

  • Serves as an internal consultant to the business and technology auditors across the audit group regarding business risks. Applies a significant depth of expertise in business and/or technology risk and control related matters to enable audit teams and ensure risk is properly evaluated in audit work. Leverages technical business expertise to influence appropriate audit coverage and assurance, such as investment instruments and product intricacies, regulatory considerations on a global scale (including the broker-dealer landscape) and/or Sarbanes-Oxley depth
  • Owns a portion of the audit plan and the associated senior business leader relationships. Manages, plans and executes the audit activities for the business areas assigned. Develops the audit strategy for specific audits that includes clearly defined identification of risks, control objectives, and audit approach. Directs the preparation of or prepares detailed audit activities to be performed to accomplish the audit strategy
  • Leads and manages complex audit projects for the organization assessing business and technology risks. Serves in an advisory capacity in support of enterprise-wide initiatives related to new business ventures and technologies (Vanguard programmatic strategic initiatives) being implemented locally and or globally
  • Leads discussions and consults with audit, business and technology leaders to assist in the development of an annual plan. Works closely with all levels of management in the planning, development and execution of short and long term goals. Demonstrates initiative and creativity in independently recommending and implementing solutions
  • Evaluates audit results ensuring the quality of the audit activities and the audit requirements are met in adherence to the professional standards of internal auditors and in keeping with our position as the independent third line of defense for the organization. Ensures audit deliverable is accurate, complete, and addresses key risks
  • Performs research to understand new business activities, technologies, data, associated risks, and the application to Vanguard’s business and technology environment to support specialized topics across multiple domains
  • Undergraduate degree or equivalent combination of training and experience. CPA, CIA, CFA or MBA also preferred as related to one’s area of expertise
  • Eight to ten years of experience in the audit profession required; five years of project management experience with experience in shaping / implementing future strategies preferred
  • Excellent leadership, interpersonal, verbal and written communication, presentation, and problem solving skills
  • Ability to lead and motivate others
  • Experience in situations requiring diplomacy and negotiation
  • Strong client focus and relationship skills
  • Advance organization integration
113

Lawn & Garden Regulatory Manager Resume Examples & Samples

  • Develop and implement robust regulatory strategies to support L&G-related portfolio of assigned active substances and products in China through
  • Planning, project management and issue management skills
  • Negotiation and advocacy skills
  • Good understanding of the L&G Business
  • Regulatory experience in China
  • 5-10 years in Reg. Sciences
114

Logistics Regulatory Manager, China Resume Examples & Samples

  • Contributes to the development and execution of the Global Logistics Operating Plan in terms of regulatory requirements
  • Research and determine import and export requirements of international and country-specific regulatory bodies (MOH, CIQ, DOH, SFDA etc.) in China and current countries serviced
  • Develop and implement appropriate communication channels to support all functions in China across R&D Labs for their specific regulatory requirements
  • Develops systems that assure compliance with regulatory requirements across the R&D Labs and monitors compliance with procedures and practices
  • Work in cooperation with the internal departments and external regulatory bodies to ensure a seamless flow of supplies movement to meet needs
  • Establish emergency contingency and shipment recovery plans and procedures to compensate for regulatory changes that may disrupt operations, such as customs closings, etc
  • Understand documentation requirements for international shipping and country-specific regulatory compliance, including dangerous goods regulations and restrictions, what level of detail is necessary, and what forms are needed and strictly comply with these requirements
  • Effective and timely adherence to management communications, meetings and procedures
  • Strict adherence to company corporate policies
  • Perform other duties as assigned by the Global Logistics management
  • Minimum of 5 years of proven experience in Logistics and/or Transportation within the CRO industry, or a reputable international transportation company or an international industrial company with track records of managing Logistics team
  • Minimun of 5 years of proven experience managing regulatory for an international company managing import/export of regulated materials and requiring regular contacts with government officials
115

Safety Compliance & Regulatory Manager Resume Examples & Samples

  • Ensure DOT, FRA, OSHA, EPA, DEQ, DNR, SITLA, DHS and all other applicable federal, state and local regulatory permits and compliance practices are implemented
  • Develop and maintain a list of external regulatory reporting requirements as well as the comprehensive calendar for reporting
  • Establish and maintain productive relationships with state, local, and other regulators
  • Maintain compliance with required filings and reporting, ensuring all agency filings are accurately completed and timely submitted
  • Implement onsite Process Safety Management program and procedures
  • Coordinate reporting and permitting issues with marketing, operations, and construction activities
  • Standardize, update, and produce written operating procedures and plans
  • Conduct regular compliance audits and trainings
  • Coordinate with Terminal Manager in the collection of relevant data to ensure up-to-date and accurate reporting
  • Develop and manage a system which provides for site document control
  • Coordinate provision of appropriate training resources to ensure all statutory and regulatory training requirements/needs are met
  • Conduct periodic safety inspections and initiate action to eliminate workplace hazards
  • Recommend installation of safety guards, safe working practices, and use of personal safety equipment
  • Support and/or lead (as requested) all accidents/incidents, maintaining complete accident statistics and records, ensuring subsequent action items resulting from investigation are resolved in a timely and satisfactory manner
  • Ability to understand and monitor Federal and State regulations, laws, and requirements
  • Ability to make appropriate, evidence-based, professional judgement when faced with complex issues and requirements
  • Understanding of regulatory language and ability to translate regulatory language into operational plans, processes, procedures, and reporting
  • Knowledge of regulatory divisions, structures, and processes including OSHA, FRA, FERC, EPA, DEQ, DNR, DOT, etc
  • Excellent interpersonal skills, including the ability to work with different departments and with various levels of company employees, customers, contractors, and government personnel
  • Demonstrate personal initiative and self-motivation
  • Strong organizational, planning, and analytical skills, ethical orientation, attention to detail, and ability to multi-task
  • Strong critical thinking, influence, negotiation skills, judgement, and ability to conduct professional meetings
  • Conversant with environmental reports and government approvals; experience with leases, contracts, bonding, insurance, mining/construction permits, conditional use permits, surveys, easements, construction documents, entitlements, site compliance, and cultural resource and environmental mitigation
  • Excellent communication skills, both written and verbal; strong business writing ability
  • Proficient in MS Office (Outlook, Word, PowerPoint, Project, Access, and Excel), AutoCAD, Adobe Suite
  • Must be committed to working safely at all times
  • Maintain a valid driver’s license
  • Bachelors degree is preferred
  • Education or working knowledge in land use development, public administration, regulatory affairs, law or a related field is preferred
  • Experience and understanding of PSM principles is highly desired
  • A recognized certification or experience in project management is desirable
  • The employee must occasionally position, transport and/or move up to 25 pounds
  • While performing the duties of this Job, the employee is regularly required to
116

Regulatory Manager Resume Examples & Samples

  • Responsible for filing of clinical trial applications to the Health Authorities in the Nordic countries, and all following interactions, in line with BMS company policies and practices, the EU clinical trial directive and the local legislation
  • Streamlining and simplifying of local work processes for clinical trial applications, and to ensure alignment of these with the new EU clinical trial regulation
  • Monitoring local health authority requirements related to the implementation of the new EU clinical trial regulation and to ensure integration of these in the local working processes
  • Foster a close collaboration with the local Clinical Operations department
  • University degree or other relevant higher education within health care
  • Preferably at least 2 years experience in pharma industry, either in clinical trial or regulatory departments
  • Excellent knowledge of MS Office (Word, Excel and Power Point)
  • Knowledge of the Finnish language is a big advantage
  • Good communication and interpersonal skills - ability to work in a team, support and foster team spirit and facilitate best practice sharing
  • Good project management and organization skills
  • Drive and can do attitude. Proactive mindset with commitment to meet and exceed external and internal stakeholder’s expectations
  • Service minded, independent and able to organise the daily work in a structured way
117

Regulatory Manager Resume Examples & Samples

  • Manage submission activities in the L&G area by partnering with key stakeholders (i.e. commercial, biology and project managers, Global/Regional/Country regulatory
  • Manage all activities of assigned products that are specific to L&G and assure that agreed, existing L&G uses and L&G products are registered on the AME market
  • Agree with key stakeholders on the projects to go forward and on the relevant gaps to be defended and registered
  • Make sure that all involved functions such as Product Safety and L&G Biology, deliver their tasks in a timely manner and on purpose
  • Develop knowledge in EU and AME registration processes and requirements for biocides and provide guidance to stakeholders accordingly
  • The person will report to the Lawn & Garden Team Lead within the EAME Regulatory Portfolio
  • Collaborate with key stakeholders to develop the AME L&G portfolio and deliver the required registrations
  • Carefully identify L&G products that need AME registration activities. Drive the preparation of L&G registration dossiers and deliver them according to plans, to AME countries
  • Identify and properly plan resources/time/budget for delivery of registration dossiers
  • Identify, drive and coordinate activities, engage resources, that are needed to deliver assistance to AME countries for answering questions from authorities on L&G products and to get registration dossiers complete and ready on time. Deliver registration dossiers to countries
  • Recognize issues or opportunities that can affect or influence projects, inform customers and respond quickly to resolve problems, e.g. with authorities, or to propose options to achieve desired outcomes
  • Alert L&G Global regulatory team on all internal and external issues and opportunities that can impact global L&G projects and propose strategies that overcome issues and/or accelerate "go to market"
  • In depth knowledge of licence to sell principles and requirements
  • Technical background with some knowledge and experience of AME regulatory requirements
  • Solid knowledge of internal processes or ability to quickly acquire knowledge of internal processes
  • Technical background, Degree in science
  • Minimum 2 years of working experience in registration or relevant development business area
  • Good networking and communication skills across international dimensions. Team player
  • Capability to lead team geographically dispersed and cross functional
  • High organisational skills, attention to detail and ability to complete and deliver projects on time
  • Proactive behaviour
  • Excellent analytical thinking ability
  • Open to novelty, "unusual" solution, pragmatism
  • Ability to recognize issues or opportunities and to create relevant alerts or options
  • Potential and ambition to develop into broader Regulatory Manager role as experience develops
  • Collaborate across boundaries
  • Focusing on delivery the dossiers according to plans
118

Air Permit / Regulatory Manager Resume Examples & Samples

  • Partner with businesses to review proposed project changes to evaluate permitting needs and provide optimal solutions to ensure project timelines are met and emission increases are minimized
  • Lead air approval projects through the preparation of permit (NSR, NNSR, PSD, PBR, Standard, Title V off-permit notifications and minor and significant revisions) applications and agency negotiations to ensure optimal permit conditions that provide competitive advantage, frequently working with consultants
  • Partner with plant personnel in the implementation of air approvals into plant operating discipline by providing interpretation guidance and inspiring open communication and leveraging between plants
  • Coordinate agency information requests to ensure accurate, timely responses
  • Lead Dow personnel in inspections/investigations (both on-site and “records review”) by local, state, or federal agencies in a mutually respective environment
  • Provide technical input and/or lead efforts to evaluate Industrial Park impact to permits on integrated sites
  • Function as site focal point to support and lead preparation and submittal of routine compliance reports to agencies
  • Assist plants in preparation of Title V Deviation reports and other regulatory reports, driving a standard of excellence is site consistency in reasonable inquiry and deviation reporting
  • Review proposed project changes to innovatively evaluate permitting needs
  • Facilitate optimal compliance issue resolution by valuing diversity of team members
  • Evaluate impact of proposed regulations on site plants and facilities; provide constructive comments to agencies for flexibility that is protective of the environment
  • Facilitate sustainable implementation of new regulations in site facilities
  • Calculate netting of key emissions (NOx, CO, PM, VOC, GHG)
  • Pursue an excellence in operating discipline to ensure consistency among site and state air permit writers
  • Partner with consultants to perform impacts and other modeling
  • Coordinate Texas EH&S Audit Privilege correspondence as service to clients
  • Work schedule is optional 9/80 or conventional 5 - 8's
  • Work is primarily in the office, with minimal travel to Austin and occasional visits to plants
  • Experience in Texas air permitting (application development and negotiating conditions/limits) for chemical/petrochemical production facilities is preferred
  • Manufacturing experience in chemical/petrochemical plant operations is preferred
  • Experience with agency investigations is preferred
  • Ability to handle a variety of tasks simultaneously and prioritize effectively to meet internal and external deadlines is preferred
  • Demonstrate strong written and oral communications skills, as this position requires interaction with various levels of Dow management, as well as interaction with government agencies is preferred
  • Demonstrate strong logical thinking and computational skills in order to ensure compliance with permit limits is preferred
  • Enthusiastically pursue a standard of excellence by developing innovative solutions to provide maximum operational flexibility and competitive advantage is preferred
  • Must have a strong sense of integrity is preferred
  • Value working constructively in teams, as well as independently is preferred
  • Ability to lead project meetings and giving presentations to small and medium sized groups of people is preferred
  • Proficient in standard MS Office applications (Word, Excel, PowerPoint) is preferred
119

Regulatory Manager Resume Examples & Samples

  • At least 7 years of bio-pharmaceutical industry experience with a doctorate degree or 10 years of experience with a Bachelor's degree of which at least three should include relevant regulatory affairs experience (eg antibodies)
  • Understanding of biologics work processes
  • Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues
  • Working knowledge of US and EU regulatory requirements for biologicals
  • Ability to interpret compliance requirements for the creation or review of protocols and site documentation
  • Agencies and Industry trends across all areas of GXP to anticipate the needs of both the company and the customers and communication of these trends
  • Demonstrated skills managing project timelines
  • Proven experience of preparing and authoring IND, NDA/BLA, and CTD submissions for biological products
  • Proficient with Microsoft Office products
  • Superb organizational skills and attention to detail
  • Demonstrated ability to manage priorities and work under tight timelines
  • Able to work in a diverse environment to obtain solutions based on a solid background and understanding of the company procedures, regulatory guidance, current legislation and company objectives
  • Able to communicate a site regulatory compliance philosophy internally and to clients
  • Demonstrated ability to work well with cross functional teams
  • Ability to review and critique complex technical documents
  • Strategic approach and system oriented toward goals and objectives
  • Ability to represent the company on regulatory issues both internally and externally
  • Strong interpersonal skills and ability to interact positively with all functions
  • Excellent team leader as well as committed team member
  • Strong written and verbal communication; ability to present to various audiences’ levels
120

CMC Regulatory Manager Resume Examples & Samples

  • Bachelor degree in pharmacy, chemistry or related scientific discipline or equivalent qualification
  • Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions
  • Detailed knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development
  • Proven ability to develop and implement complex regulatory strategies and evaluate the potential impact of them on overall project/product strategy
  • Successfully influenced and negotiated issues at a senior level within your organisation and with regulatory agencies in a variety of settings
  • Proven ability to manage and direct multiple projects/teams simultaneously with excellent team working abilities and adjust to changing priorities
  • Experience in corporate evaluation and provision of CMC regulatory advice to in-licensing and divestment projects
  • Experience of being involved in/leading business critical activities within and external to the organisation
  • Manage, or be responsible for, the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities
  • Strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and early lifecycle activities
  • Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications
  • Work in cross-functional matrix project teams, which include colleagues from regulatory, chemical and pharmaceutical development and manufacturing
  • Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment
121

Senior Global Program Regulatory Manager Resume Examples & Samples

  • Strong knowledge of regulatory submission and approval processes in 1 or more major regions
  • Experience leading regulatory submissions and approvals in at least 1 major region
  • Experience in a global/matrix environment or crossfunctional teams in the pharmaceutical industry
  • 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas
  • Prior history with post-marketing/brand optimization strategies and commercial awareness preferred
  • Involvement in dossier submissions and approvals
  • Drug regulatory submissions and commercialization in major regions
  • Organizational awareness (e.g., interrelationship of departments)
122

Senior Regulatory Manager Resume Examples & Samples

  • Review TCCC flavors for compliance with government and Company requirements and develop regulatory documentation to support product development initiatives
  • Track, monitor and understand current, proposed and new flavor regulations to assess impact on the business as well as promote and participate in advocacy efforts
  • Formulate and propose positions on key flavor issues and develop proposed language for FAQs, advocacy discussions, and other settings
  • Establish, communicate, and enforce Company requirements regarding flavor regulatory issues
  • Collaborate with flavor suppliers’ regulatory departments regarding compliance activities
  • Actively work with trade organizations including Flavor Extract Manufacturer’s Association (FEMA) on flavor issues of importance to the Company and the industry and represent the Company on relevant committees
  • Create flavor regulatory training modules and train internal and external stakeholders
  • Work with Company regulatory managers worldwide to obtain and maintain key flavor and labeling regulations and to consult on their meaning and application
  • Flavor Regulatory Knowledge: General knowledge of the flavor regulatory landscape that affects the food and beverage industry. Understands the flavor regulatory frameworks of different countries. Ability to interpret global flavor regulations. Is aware of the major flavor regulatory issues facing the food and beverage industry
  • Flavor Regulatory Documentation: Ability to review, interpret and summarize complex regulatory and technical information and develop regulatory documentation such as legality certificates, natural status certificates and allergen statements for use in compliance reviews
  • Flavor Industry Knowledge: Knowledge of flavoring materials, the flavor industry and the trade organizations that represent them
  • Proprietary Composition Information: Ability to recognize and protect proprietary information as it relates to formulas and ingredients
  • Flavor Chemistry: General knowledge of the chemistry of essential oils and other flavor compounds relevant to Company products
123

Senior Regulatory Manager Resume Examples & Samples

  • Provide expertise to guide the business in finding solutions to hazard communication and chemical regulation compliance issues that affect our products, ingredients, and labels
  • Ensure information in Master Database related to hazard communication is accurate and current based on available information
  • Establish, communicate and enforce Company requirements regarding hazard communications
  • Provide support and guidance on Safety Data Sheet (SDS) requirements
  • Maintain a strong network of experts, government agencies, industry peers and other stakeholders needed to maintain a favorable regulatory environment for the company. Represent the company externally on relevant trade and scientific organizations
  • Influence, review and monitor new/changing global regulations so that leadership can be proactively informed of emerging hazard communication and chemical regulatory issues that are an impact to the business and identify strategies to address them. Interpret, assess business impact and implement new regulations as required
  • Partner with the business and internal manufacturing to identify needs to meet current and future requirement for hazard communication
  • 7+ years relevant work experience. Experience in the fields of hazard communication, Safety Data Sheets, and transportation classifications, preferably with a flavor/fragrance, consumer product or chemical company
  • Hazard Communication and Chemical Regulations Knowledge: General knowledge of hazard communication and chemical regulations as it applies to ingredients, flavors and beverage bases. Ability to interpret global hazard communication and chemical regulations
  • Hazard Communication and Chemical Regulatory Landscape: General knowledge of the hazard communication and chemical regulatory landscape that affects the food and beverage industry. Understands the regulatory frameworks of different countries. Is aware of the major regulatory issues facing the food and beverage industry
  • Build Technical Relationships: Ability to apply technical knowledge and establish credibility with highly technical audiences in order to build relationships. Advocates a position in a non-adversarial manner
  • Technical Requirements: Ability to develop and implement company requirements and guidelines on hazard communications
124

Senior Regulatory Manager Trade & Industry Resume Examples & Samples

  • Responsible for leading the Regulatory Analysis function within Oriflame ensuring the business impact on Oriflame portfolio of new legislation in cosmetic and food and food supplement areas is minimised
  • Support Senior Director Global Regulatory Affairs in the on-going development and implementation of the global regulatory strategy aligned with R&D and overall company strategy
  • Management of the Global Regulatory Analysis team in R&D in line with Oriflame requirements and career development aspirations
  • ’Dotted line’ management of Oriflame Regional Regulatory team ensuring focus areas and targets are aligned with Global Regulatory strategy
  • Work with Senior Director Global Regulatory Affairs in developing the future strategy for Oriflame’s advocacy/lobbying efforts at Trade Association level
  • Represent Oriflame on relevant National & European Trade Association Committees/Working Groups
  • Responsible for building effective network of external regulatory contacts across industry thereby enabling stronger lobbying positions on regulatory matters important to Oriflame
  • Build and maintain a high level of expertise and knowledge in the regulations affecting compliance of cosmetics and food/food supplements in all Oriflame markets
  • Effective and proactive communication of regulatory challenges and risk areas to senior management within the organization
  • Post Graduate qualification in a scientific discipline is required
  • At least 5 years experience in a senior regulatory role preferably within the cosmetic or food/food supplement sector
  • Broad experience in representing a company at trade association level is required
  • Broad knowledge of regulations relevant to cosmetic or food/food supplements in global markets is mandatory
  • Proven track record of successful communication of regulatory matters to various non-technical audiences is required
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Regulatory Manager Resume Examples & Samples

  • Obtain approval for specific Syngenta products in the Nordic countries (Norway, Sweden, Finland & Denmark) to timescales agreed with Regulatory Lead and Commercial Unit
  • Actively contribute to securing Syngenta’s competitive edge through top quality submissions and handling registration issues in an ethical, trustworthy way with Nordic authorities
  • Knowledge on the Nordic/EU PPP (Plant Protection Products) matters
  • Knowledge on PPP legislation and legislation connected to PPP authorisation in Nordic countries and at EU level
  • Knowledge of the technical disciplines related to PPP registration; toxicology, product residues, environment fate and ecotoxicology at a general level
  • Deliver value adding solutions to the Nordic CU business
  • Effective collaboration within the regulatory team
  • Internal & external networking
  • High attention to detail whilst keeping the overview
  • General understanding of agriculture and horticultur business
  • Practical registration experience
  • A degree in Science
  • Experience in building and maintaining relationships
  • Proven cross functional working capabilities
  • Proven experience in providing solutions to complex issues
  • Proven communication, negotiation, influencing and analyttical capabilities
  • Fluent in Danish/Swedish and English
  • Capability to work in highly structured and independent manner
  • Excellent administrative skills (attention to detail whilst maintaining the overview)
  • Excellent project management capabilities
  • Ability to act in a trustworthy and responsible manner
  • Ability to multi task on different levels
  • Networking capabilities to effectively build and maintain a solid internal and external network
  • Ability to act as a decisive team player
  • Ability to prioritise and deliver goals on time
  • Sets ambitious strategic goals
  • Manages for performance
  • Collaborates across boundaries