Regulatory Affairs Resume Samples

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E Tremblay
11307 Clyde Lake
+1 (555) 166 8307
11307 Clyde Lake
p +1 (555) 166 8307
Experience Experience
Phoenix, AZ
Regulatory Affairs
Phoenix, AZ
Hodkiewicz Group
Phoenix, AZ
Regulatory Affairs
  • Trading is interested in attracting people who share our core working values of honesty, integrity and respect for others
  • Supports senior Regulatory personnel in preparing new product marketing submission for the FDA (510k, PMA)
  • Provide regulatory and compliance interpretations to Marketing and Sales on labeling issues
  • Initiates and/or assists with trending of documentation metrics for company Management Review and additional meeting forums
  • Acts as training coordinator for ADC Germany, Austria and Switzerland
  • Management of customer requests regarding quality or regulatory related issues
  • Conducts product inspections, i.e.: receiving and integration with department administrative staff
Philadelphia, PA
Regulatory Affairs Administrator
Philadelphia, PA
Cartwright, Mosciski and Mitchell
Philadelphia, PA
Regulatory Affairs Administrator
  • Management of all filing, copying and preparation of new product submissions and variations under the direct supervision of the Regulatory Affairs Manager
  • To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485
  • Management of OPAL events, variations and approvals for SSA
  • Management of Product Information Files and Medical Device Technical Files
  • Assist in finding product information from Regulatory Affairs databases in response to requests from Intervet International
  • Setting up of SSA meetings for the team, ensure minutes and agenda are sent out prior to meeting and ensure minutes are captured and agreed prior to dissemination to team
  • Assist with regulatory export control and stickering as necessary
Philadelphia, PA
VP Government & Regulatory Affairs
Philadelphia, PA
Philadelphia, PA
VP Government & Regulatory Affairs
  • Oversee all franchise renewals including managing.. efforts to ensure compliance with franchise obligations
  • Proven success driving progress and executing in a fast paced, dynamic and complex environment
  • Proven success developing people and building solid teams
  • Responsible for relations with Virginia and West Virginia state governments, including advocacy before the legislature, executive branch, and state agencies
  • Coordination with Division and Corporate leads on other regulatory matters involving Comcast
  • Consistent exercise of independent judgment and discretion in matters
  • Consistent exercise of independent judgment and discretion in matters of significance
Education Education
Bachelor’s Degree in Pharmacy
Bachelor’s Degree in Pharmacy
University of Delaware
Bachelor’s Degree in Pharmacy
Skills Skills
  • We also want those who can build on our business vision, are prepared to accept accountability and can achieve great results through teamwork
  • Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills
  • The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties
  • Determination of level will be based upon years of experience & demonstrated knowledge/skills
  • The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work
  • A mature and disciplined approach to work is essential as is the ability to coordinate the work of others
  • Fluent in English (written & spoken). Ability to communicate in German language (written & spoken) is a distinct advantage
  • Ability to plan and schedule multiple priorities in a concurrent fashion
  • Ability to review, collate and summarize scientific and technical data
  • Excellent problem solving and analytical skills
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15 Regulatory Affairs resume templates


Senior Analyst Regulatory Affairs Resume Examples & Samples

  • BS in Business, Finance, or related field
  • 5 years of industry experience required; preferably compliance experience
  • Series 7, 63/66, 9 and 10 required
  • Strong understanding of SEC, FINRA, MSRB rules/regulations, industry practice and how they apply to Stifel and affiliated firm policies and procedures
  • Demonstrated skills in organization, strong attention to details, prioritizing and managing time, multiple tasks and varying priorities in order to meet critical deadlines
  • Interpersonal Relationships — Developing, and maintaining constructive and cooperative working relationships with others, and sustaining them over time
  • Technical Writing – Able to gather information from research, existing documentation and subject matter experts, and effectively explain complex ideas to technical and non-technical audiences
  • Active listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times
  • Judgment and Decision Making – Considers the relative cost, benefits, and firm policy of potential actions and to choose the most appropriate action according to Firm and Team risk

Office of Regulatory Affairs Resume Examples & Samples

  • Identifying emerging regulatory policy issues for the Corporate and Investment Bank
  • Defining regulatory policy priorities through impact assessment and engagement with internal and external partners (internal business leaders, government relations, media relations, industry trade associations, etc.)
  • Leading internal working groups governing the development of regulatory policy strategies
  • Developing appropriate public policy positions and advocacy strategies
  • Leading/participating in dialogue with regulators and policymakers
  • Ensuring handoff to internal implementation leads as rules become final
  • Minimum of 10-15 years of experience
  • Strong background and understanding of fixed income and equity capitalmarkets, OTC derivatives, and futures markets
  • In depth knowledge of Dodd-Frank Act Title VII requirements, CFTC, SEC, andbanking regulations
  • Strong understanding of MIFID, EMIR, and European securities regulation
  • Strong written and oral communications skillls

Disney Vacation Club Management & Regulatory Affairs Internship Resume Examples & Samples

  • 0 GPA or higher
  • Demonstrated problem Solving and analytical/critical thinking skills
  • Relationship/Partnering skills
  • Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint
  • Service Orientation (customer service)
  • Japanese and/or Spanish skill set
  • Experience working in Real Estate
  • Experience working in a bank environment, specifically dealing with mortgages
  • Disney knowledge
  • Currently enrolled as a junior or higher, or graduated within 6 months of the start date of this internship, in an accredited college/university earning a degree majoring in Business Administration, Law, Public Policy/Regulatory Affairs, Communications, Hospitality Management, Real Estate, Finance/Accounting or related major

Counsel, Regulatory Affairs Resume Examples & Samples

  • JD and BA/BS degrees
  • Active state bar membership
  • Minimum 6-8 years relevant regulatory experience, including law firm experience

Regulatory Development Manager FCC RC Regulatory Affairs Resume Examples & Samples

  • This role also needs to lead without authority and able to collaborate with multi stakeholders and deliver results. The role holder must be able to influence senior management and regulators by articulating clear business reasons for change initiatives
  • Bachelor’s degree in business, law, or related field or equivalent experience. LL.B or legal experience not required but considered an asset
  • Five to seven years proven and progressive financial services, compliance and/or legal experience or equivalent
  • Specialized knowledge of legislative compliance management programs as contemplated by OSFI Guideline E-13, legislation and regulatory directives relating to conduct, control of information, privacy, securities, financial crime relating as they apply to financial groups and extra-territorial laws applicable to Canadian financial groups such as Dodd Frank
  • Wide scope of knowledge and ability to review and understand complex regulatory regimes impacting a complex global financial group
  • Highly developed communications, negotiating, analytical, decision-making, organizational and planning skills
  • Wide scope of knowledge of financial institutions, including products, operations, systems and organization
  • Good understanding of all significant regulatory regimes applicable to Canadian financial institutions, a global financial group, and pertinent Group policies and external regulations

Office of Regulatory Affairs Resume Examples & Samples

  • Management Information Lead: Own the development and distribution of management reporting on emerging regulation to various stakeholders across the firm. Define and coordinate daily, weekly and monthly reporting across LOB and regional partners. Deliver organized, consistent results
  • Global Governance Coordinator: Manage Global Regulatory Policy Governance by partnering with Regulatory Affairs colleagues, LOB partners, Legal, Government Relations, and other key stakeholders to ensure escalation, ownership and issue capture for all emerging regulatory policy matters . Coordinate development of meeting materials for global and cross-LOB escalation forums and ensure follow up with appropriate stakeholders
  • Process improvement: Identify opportunities for process and efficiency improvement in tracking of emerging regulatory issues both within the team and across LOB and corporate partners. Drive systems, process, and technology improvements
  • Business management support: Assist with business management for the team including liaising with finance and accounting teams and ensuring proper strategic planning and forecasting for the global team
  • Briefings: Assist in the coordination and development of briefings for Senior Management for meetings with regulators, investors, and other stakeholders on regulatory policy issues
  • Ad-hoc projects: Assist with management of other reporting related projects, including presentations
  • Focus on service delivery / client satisfaction
  • Strong coordination and influencing skills, ability to work across business lines and jurisdictions
  • Must be detail-oriented and manage the details but can also summarize information at high levels
  • Strong time management skills with ability to manage multiple projects and time sensitive deliverables
  • Ability to work with multiple, complex systems and large volumes of information
  • Ability to help identify and recommend improvement in systems and processes
  • Proactive, responsive, creative and action oriented
  • Strong familiarity with bank regulatory issues strongly preferred

Regulatory Affairs Program Office Associate Resume Examples & Samples

  • Strong communication, presentation and project/program management skills
  • Candidates must be self-motivated, independent and organized
  • 4-7 years of experience in financial services, management consulting and/or project management
  • Project Management Professional (PMP) or other Project Management (PMI) certification
  • Proficient with MS Access, Visual Basic for Applications (VBA)

Regional Regulatory Affairs Director Resume Examples & Samples

  • Develop and lead a global regulatory organisation, both centrally & regionally. Lead Regulatory KPI reporting, trending and review. Lead strategic vision for the R&D function through maximising the Regulatory landscape we operate in. Facilitate the promotion and protection of IP. Represent the company in negotiations and discussions with the key industry regulatory decision makers and competent authorities as required
  • Strategic responsibility for proactively influencing, leading & communicating on regulatory affairs externally & in parallel ensuring that all products are globally compliant for sale within EMEA
  • Maintenance and implementation of the Regulatory management system, Optiva, MDM etc
  • Create and drive the global regulatory organisation goals & objectives in line with the global regulatory strategy
  • Monitor potential changes in regulations and proactively liaise with relevant regional R&D representatives and/or local competent authorities in order to minimize any impact to the business
  • Ensure continuous regulatory expertise and knowledge across the organisation
  • Analysis and impact assessment of upcoming changes to existing regulations, partnering with the Supply Chain and advising on impact to supply chain and distribution processes
  • Support New Product Development through participation at product brief and artwork development stages. Providing expertise and direction on product classification and product claims during the NPD Process
  • Develop and manage the central regulatory team, ensuring a high level of regulatory expertise and resource which integrates with the global RD&A/regulatory organisation. (50 people)
  • Liaison & communication with Corporate Legal on strategic and operational regulatory issues
  • Minimum of 5 years work experience as a Functional leader for a Global Food business or related industry
  • Minimum of Degree level Food science or Science related disciplines,
  • Expert observation, analysis and judgement (i.e. analytical and objective mind-set)
  • Strong background in Food Science & Regulatory standards
  • Knowledge of Process management systems and document control
  • Ability to work with cross-functional teams at multi levels within the organization
  • Excellent Interpersonal, communication, coaching and conflict management skills
  • Ability to lead and project manage a cross functional team
  • Proven track record of driving continuous improvement and change management initiatives
  • Direct Customer Management experience essential

Office of Regulatory Affairs Corporate Summer Intern Ny Resume Examples & Samples

  • Strong interpersonal leadership and influencing skills
  • Results-orientation - takes initiative to identify areas to add value and executes quickly and accurately
  • Excellent project management skills and attention to detail, ability to prioritize issues and manage competing tasks
  • Analytical and data management skills
  • Excellent communication skills (both oral and written)
  • Outstanding ability to analyze problems, identify key dimensions of a problem and propose solution
  • A track record demonstrating a high level of personal initiative, setting and achieving challenging goals, and demonstrating entrepreneurial leadership
  • Demonstrated interest in regulatory policy issues affecting the financial services industry
  • Intermediate to advanced MS Excel, Word and PowerPoint skills

Regulatory Affairs NDA Consultant Resume Examples & Samples

  • 8+ years of Regulatory experience respectively within the Pharmaceutical or Biotechnology industry
  • Bachelor's Degree in a Scientific field
  • Experience directing the preparation of eCTD NDA submissions
  • Solid understanding of FDA regulations and ICH guidances, as well as comprehensive experience in the drug development process
  • Solid problem solving and negotiation skills
  • Ph.D. or Pharm. D
  • Regulatory Affairs certification

Office of Regulatory Affairs Resume Examples & Samples

  • Identifying and analysing legislative and regulatory proposals on a variety of upcoming financial regulatory change initiatives in terms of application to and impact upon current JPM business. Proposals are predominantly EU and UK driven but are considered, where relevant, in the context of the international agenda e.g. IOSCO, FSB, and emerging US policy, to ensure a holistic appreciation of policy goals
  • Building relationships and working with a wide range of stakeholders (line of business, compliance, legal, government affairs, and finance) in determining the firm's views on proposals and the appropriate mechanism for advocacy/response
  • Drafting position papers, response documents and other analytical pieces for a variety of audiences
  • Representing the firm’s views in discussions with regulators, legislators and other appropriate external stakeholders
  • Bachelor's Degree or equivalent in a complementary discipline would be a distinct advantage – including candidates with a legal qualification/background
  • Proven professional experience with an investment bank, regulatory body or private law firm
  • Sound working knowledge of financial services regulation in the EU
  • Excellent verbal/presentation and written communication skills
  • Flexible and proactive in approach
  • Good basic grasp of prudential regulation would be a distinct advantage, as would competency in a European language

Office of Regulatory Affairs Executive Director Based Resume Examples & Samples

  • Chief Operating Officer for the group:manage strategic planning, regulatory relationship management, resource allocation, hiring, internal and external communications including with industry bodies and trade associations
  • Leading and supporting virtual teams: Partner with ORA team members, finance, strategy, risk, government relations, communications and LOB teams to develop positions on high priority regulatory policy matters
  • Head of Regulatory Affairs for the Commercial Bank:identify emerging regulatory policy issues, define regulatory policy priorities, and lead dialogue with regulators and policymakers to achieve optimal outcomes for the line of business
  • Manage internal governance, reporting, and coordination among regions and lines of businesson emerging regulatory reform issues, ensuring appropriate issue capture, escalation, internal communication, and accountability
  • Lead firm-wide and cross-region projects on global regulatory reform issues including development of analytical support for policy positions
  • Manage team of 5 which supports executives globallyon a project basis covering a range of global and domestic regulatory policy issues (including drafting of oral and written presentations and speeches)
  • Significant regulatory experience including team management experience
  • Experience with bank regulatory policy issues
  • Strong relationships with regulators, policymakers, and trade associations globally
  • Excellent analytical, organizational, and problem solving skills
  • Ease working across a range of geographies
  • Ability to effectively engage senior leaders around the firm
  • Ability to clearly communicate and present information both verbally and in writing
  • Advanced technical skills in Excel and PowerPoint
  • Master’s Degree or equivalent in a related subject

Regulatory Affairs Consultant Resume Examples & Samples

  • The propose of the role is to provide Chemistry Manufacturing and Controls (CMC) Regulatory Guidance and strategy to support the development of assigned projects within the Biologics and Vaccines portfolio, up to and including MAA / BLA submission
  • The role will also have responsibility to author and manage the submission of clinical trial applications (INDs, IMPDs, CTAs), briefing documents, etc. as they relate to CMC
  • Provide CMC regulatory advice and guidance to co-development teams that manage the development of Biologics and Vaccines
  • Plan, manage, author and submit CMC content for clinical trial applications, amendments etc
  • Ensure that submission and approval schedules are met to facilitate timely conduct of clinical trials
  • Develop high quality responses to BOH questions arising from clinical trial application submissions
  • Develop BOH communication materials as required, e.g. BOH meeting briefing documents, scientific advice requests
  • May provide strategic input and support the development of the initial MAA / BLA Complies with Department and Company Standard Operating Procedures (SOP's) relevant to the position

Regulatory Affairs Operations Lead Resume Examples & Samples

  • Bachelor's Degree in a Natural Sciences field
  • Experience with either EPA or FDA registered products
  • Exceptional negotiating and influencing skills
  • Experience in Consumer Products industry

VP-office of Regulatory Affairs Resume Examples & Samples

  • Identifying and analysing legislative and regulatory proposals on a variety of upcoming financial regulatory change initiatives in terms of application to and impact upon current JPM business. Proposals are predominantly nationally-driven but are considered, where relevant, in the context of the international agenda e.g. IOSCO, FSB, and emerging US policy, to ensure a holistic appreciation of policy goals
  • Delivering verbal briefings and analyses to a wide range of stakeholders, including senior management
  • Participating in advocacy meetings with business and government relations colleagues and other internal stakeholders
  • Representing the firm’s views at, and coordinating with, all major industry associations in their submissions, articulating positions and playing a proactive role in forming opinions in a collegiate atmosphere
  • Higher degree or professional qualification in a complementary discipline would be a distinct advantage – including candidates with a legal qualification/background
  • Sound working knowledge of financial services regulation in the APAC region
  • Wide ranging knowledge of banking and analogous businesses and of their public policy context
  • Able to work well both autonomously and in a team environment, holding self accountable for deliverables and able to work to strict deadlines
  • Confident in dealing with senior management
  • Outstanding analytical skills
  • Ability to manage multiple workflows
  • Ability to work in an open plan team environment
  • Good basic grasp of prudential regulation would be a distinct advantage, as would competency in a regional language

Regulatory Affairs Advisor Resume Examples & Samples

  • Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible forclose liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval
  • Maintenance of marketing authorisations for nominated client via a range of regulatory activities including submission of variation applications and MA renewals
  • Communication with the appropriate competent authority to answer questions and obtain timely approval for changes
  • Implementation and communication of MA changes. Ensuring all compliance activities are correctly managed
  • Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management in line with regulatory requirements
  • Maintain sound knowledge of European regulatory requirements, regulations and guidelines to provide advice and expertise internally for matters related to client products
  • Provision of guidance/technical support in the preparation of EU CTD dossiers applications
  • Builds and maintains strong relationships with different Competent Authorities to ensure ease of access and influence
  • Works collaboratively with other department colleagues to share best practice and information and to ensure a consistent approach with both Competent Authority & within company
  • Support other team members with the maintenance of the Quality Management System and ISO 9001, including generation and review of SOPs, reports and other quality documentation
  • B.Sc. Minimum or pharmacy primary degree
  • Greater than 3 years experience of human medicinal product Regulatory Affairs in the Pharmaceutical Industry
  • Experience with electronic submissions desirable
  • Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice
  • Experience in the preparation and submission of new applications, variations and renewals for multiple EU markets
  • Experience in the management of DCP's, Centralised or other European procedures
  • Ability to project manage across a diverse and complex portfolio of products and priorities
  • Ability to get on with people, to influence people both internally and externally and to achieve objectives
  • Above average attention to detail and solid interpersonal, communication and organisational skills required
  • Excellent attention to detail with Client Care an integral part of your work ethic
  • Confidentiality and discretion
  • Motivated self-starter

Regulatory Affairs Advisor Resume Examples & Samples

  • Ability to take ownership/ regulatory responsibility for key product(s) for nominated client(s) and be responsible for close liaison with the Management/ other key personnel of the relevant business unit in the definition of product strategies in line with timeframes for approval
  • Medical writing, review of SPC, labeling and management of national prescribing information and core data sheets (CDS) during product lifecycle
  • Review of clinical and safety draft reports created by client and provide feedback within the required timeframes
  • Ability to work effectively as part of a team with a strong focus on meeting target deadlines
  • Review and appraisal of PSURs, and responses prepared by client prior to submission to competent authority
  • Apply regulatory and scientific knowledge to determine solutions and solve complex problems
  • Represent at related events and possess the ability to drive the Company forward in a positive light at all times
  • Builds and maintains strong relationships both internally and externally
  • Having some responsibility for training and coaching colleagues in your area of expertise (i.e.Pharmacovigilance)

Government & Regulatory Affairs Executive Resume Examples & Samples

  • At least 10 years experience in a leadership role that involves government or government affairs
  • At least 5 years experience in working for a large corporation or effective trade association is preferred
  • At least 1 year experience in working in government at senior level is a plus
  • At least 5 years experience in global acumen, balanced judgement
  • At least 1 year experience in verbal and written communication skills, must be excellent

Director Government & Regulatory Affairs Resume Examples & Samples

  • Prominently positioning Visa with political, regulatory and policy decision-makers to support and drive business opportunity for Visa by shaping the regulatory landscape for electronic payments
  • Support the implementation of a Government Relations strategy for China in close coordination with the Senior Director, Government Affairs and Public Policy, China Country Manager, along with other relevant Visa business leaders
  • Monitor the regulatory and political landscape for threats and opportunities to Visa's business and communicate this intelligence to locally-based business leaders, functional colleagues and global management
  • Support Visa's relationships with officials at key government agencies, including the education of officials from these agencies about the value of Visa thereby improving the company's overall reputation
  • At least 5-10 years in relevant corporate position, regulatory or government agency and/or consultancy serving equivalent clients

Manager Policy & Regulatory Affairs Resume Examples & Samples

  • Contribute to the development of global public policy and Government Affairs objectives by
  • Supporting the Bank's relationships with government contacts in Canada and other key markets
  • Identifying policy trends, threats and impacts to the Bank’s operating environment and business line plans, contributing to the Bank’s strategic plan and other internal processes
  • Proactively developing and implementing strategic and tactical plans and responses to policy developments in light of Bank and government priorities
  • Concisely synthesizing large amounts of information and communicating summaries, positions and recommendations in simple, concrete terms
  • Contribute to integrated communication strategies and tactics related to the Bank’s policy agenda and its reputation with government and related stakeholders by
  • Providing, and collaborating on, policy and research communications including issues management, reputational risk and crisis communications
  • Provide strategic advice and counsel by
  • Contributing to the development of briefing material for the CEO, Executive Management Team and SVP for meetings including those related to the elected officials, regulators, foreign governments, international organizations
  • Managing relations with the Canadian Bankers Association (CBA) and the Institute of International Finance (IIF), and supporting senior executive and senior management officers who are members of CBA senior committees and IIF committees
  • Providing intelligence, analysis and judgement on the global regulatory environment and specific policy issues of relevance to the Bank
  • Collaborating with the rest of the Government Affairs team to support work on developing briefing materials, policy analysis, and integrated counsel that combines policy and political analysis
  • Manage and keep track of political risks, policy and communications opportunities at an all-bank level and across its international network by
  • Ensuring comprehensive and timely capture of regulatory, policy and market events and trends, timely analysis and proactively preparing communications materials
  • Proactively identifying emerging policy, political, consumerist and market developments across multiple jurisdictions and international forums for review with senior officers of the Bank, including liaison with business lines and corporate functions (e.g., Strategy Management, Economics, Compliance, Finance, General Counsel)
  • Contribute to the effective functioning of the Government Affairs team by
  • Building effective working relationships across the Public, Corporate and Government Affairs team and with various business line and corporate function contacts
  • Maintaining customer focus
  • Some prior experience in public policy, government relations and/or communications

Associate Director, CMC Regulatory Affairs Resume Examples & Samples

  • Provide CMC RA leadership within RA and on cross-functional CMC teams
  • Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls
  • Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities, for commercial and/or development programs
  • 15%
  • Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products
  • Lead other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements
  • Evaluate manufacturing change controls, assess regulatory impact, and support their implementation
  • B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
  • 8 - 10 years of drug development experience including significant strategic experience in CMC regulatory affairs with a strong biologics background
  • Demonstrated leadership in regulatory strategy and experience in regulatory interactions

Office of Regulatory Affairs Resume Examples & Samples

  • Identify emerging regulatory policy issues emerging from North American and global regulators and policymakers
  • Advise internal constituents on North American and global regulatory policy matters
  • Effectively communicate JPMC’s regulatory policy positions through a variety of channels (written responses, bilateral meetings with policymakers, trade associations, legislators, etc.)
  • Represent JPMC in public forums, including conference participation, speeches, presentations, and discussions with the media
  • Manage relationships with US Regulators and policymakers including at Treasury, Federal Reserve, FDIC, and the OCC
  • 15+ years of experience in a senior leadership role, managing associated risks, policies and budgets
  • Extensive current knowledge and understanding of regulatory policy and affairs
  • Expert knowledge of the enhanced prudential standards for large U.S. bank holding companies and foreign banking organizations including liquidity, risk management, and capital
  • Proven leadership and partnership skills with proven ability to effect change within a large matrixed organization
  • Excellent oral and written communication skills with experience representing an institution in public forums
  • Strong preference for legal, regulatory agency, government or trade association experience
  • Expert knowledge of bank/market regulations strongly preferred

Publishing Assistant of Regulatory Affairs Resume Examples & Samples

  • 1+ year of experience working in a Regulatory Affairs Department or in the Publishing field
  • Bachelor's Degree in a Science-related discipline or equivalent experience
  • Understanding of eCTD submissions and current guidelines

Head of Regulatory Affairs Resume Examples & Samples

  • Establishes and implements short and long term strategies to deliver products and services to clients within reasonable schedules and budgets. Collaborates with Life Sciences Business Process Services (LS BPS) Regulatory leads and sales professionals to determine and develop product strategy and assess risks
  • Directs staff in implementation of program, product, and client management strategy. Supports team related to client and regulatory deliverables and submissions. Maintains interface with lead project managers on technical aspects of projects as well as cost and schedules to ensure timely delivery, where necessary
  • Monitors and maintains industry and market expertise and awareness of new technologies and companies to support new business. Forms and maintains critical high-level relationships with outside governmental and industrial entities for the collaboration and development of new business initiatives
  • Oversees, collaborates and conducts critical evaluations of new product development priorities, as well as existing product improvement and applications priorities, including evaluation of safety and efficacy data, significant marketing opportunities, competition, core competencies, sources of supply, manufacturing requirements, regulatory issues, profitability and other applicable criteria to support client engagements as necessary
  • Manages new product and partnership development, existing product improvement and development process, including coordination of interdepartmental responsibilities
  • Maintains currency with technical and regulatory activities on pharmaceutical and biotechnology programs. Provides technical expertise and training opportunities for staff to maintain high level skills
  • Selects and hires employees. Trains and evaluates employees to enhance their performance, development and work product. Addresses performance issues and makes recommendations for personnel actions. Motivates and rewards employees including providing salary increases, bonuses and promotions within allocated budgets and company guidelines
  • Prepares and recommends operating and personnel budgets for approval. Monitors spending for adherence to budget, recommends variances as necessary
  • Master's degree or equivalent combination of education and experience
  • Twelve or more years’ experience in one or more of the following areas: biotechnology, regulatory, Chemistry, Manufacturing, and Controls (CMC), clinical, or non-clinical
  • Twelve or more years’ experience in the development of pharmaceutical / biopharmaceutical industry Strong interpersonal skills to interact with customer and team members
  • Experience in leadership, supervisory or management
  • Experience in managing and developing senior level staff
  • Experience working with company products and offerings
  • Knowledge and proficiency of Food and Drug Administration (FDA) and international document submission requirements and regulations Strong project management skills to coordinate and manage internally and externally
  • Excellent verbal and written communications skills to effectively share concepts, ideas, information and suggestions with others
  • Strong analytical and problem solving skills
  • Strong interpersonal skills to establish and maintain client relationships through executive level
  • Ability to multi-task and work on multiple functions simultaneously
  • Ability to anticipate internal and client needs

Manager Government & Regulatory Affairs Resume Examples & Samples

  • Responsible for day-to-day contact regarding local regulatory, franchising, community investment and public policy matters for assigned footprint within the Region
  • Serve as a liaison between the company and our franchising communities, non-profit community partners and community business leaders
  • Responsible for franchise renewals, transfers and all related compliance issues
  • Represents the company before municipal boards and commissions; at community events; serves on boards of relevant organizations
  • Advocates for the company throughout assigned footprint and implements strategic plans
  • Works closely with other departments to further business objectives and to facilitate business opportunities
  • Prepares franchise-related documents, supports cases before government regulatory agencies, skilled in researching & analyzing
  • Identifies issue in the service footprint that affects the business and recommends action
  • Assists with state and federal legislative matters as needed
  • Advise on political issues within assigned footprint, alert to competitive environment and marketplace conditions
  • Harness support in the field for company’s initiatives through champion building and networking
  • Identities and coordinates community events & sponsorships supportive of business objectives and policy initiatives
  • Works with non-profit, civic and service organizations to further company’s goals of good corporate citizenry
  • Participates in all corporate giving, volunteer and grassroots programs; by way of example-Comcast Cares Day, Internet Essentials, United Way
  • Regular, consistent and punctual attendance. Must be able to work nights and

Business Analyst, Regulatory Affairs Resume Examples & Samples

  • University degree in business
  • Excellent understanding of accounting and financial concepts and processes (professional accounting designation preferred)
  • Ability to collect, aggregate, analyze, organize and clearly communicate large amounts of financial and operating data
  • High level of proficiency with Microsoft Excel
  • Strong research skills
  • Bilingual (English and French)
  • Proficiency with Microsoft Word and PowerPoint
  • Experience with Bell’s financial information systems

Scientific Regulatory Affairs Executive Resume Examples & Samples

  • Apply the Group’s regulatory affairs strategy and help implement regulations, notably for cosmetics and chemicals, in product development and marketing, with focus on operational support to the APAC country Scientific and Regulatory Affairs teams so that they can ensure market access procedures required by the local regulations
  • Provide technical and regulatory support throughout the product lifecycle, from initial research to final marketing Participate in compiling regulatory reports in line with quality standards and deadlines Contribute to ensuring compliance with relevant rules and local regulations for product market access
  • Contribute to improving or developing information systems to support APAC country Scientific & Regulatory Affairs team
  • Contribute to cross-disciplinary projects initiated within the technical-regulatory network

Office of Regulatory Affairs Resume Examples & Samples

  • Project Support: Support senior group leadership and the Central Team on longer-term research and analytical projects related to regulatory policy or policy themes
  • Research Project: Conduct a research project related to emerging regulatory policy and present findings and proposed next steps to group management
  • Management Reporting: Assist with drafting and research related to ORA’s various management reports
  • Research and Analysis: Perform ad hoc projects and research related to emerging regulatory policy
  • Strong interpersonal leadership and influencing skills
  • Results-orientation - takes initiative to identify areas to add value and executes quickly and accurately
  • Judgment and professional maturity to handle sensitive information and work with senior management
  • Excellent communication skills (both oral and written)
  • A track record demonstrating a high level of personal initiative, setting and achieving challenging goals, and demonstrating entrepreneurial leadership
  • Demonstrated interest in regulatory policy issues affecting the financial services industry

Regulatory Affairs & Quality Systems Manager Resume Examples & Samples

  • Works with senior management to develop regulatory strategies for FDA approvals. Directs the division’s FDA regulatory activities and initiative, assures the quality of its records and products and ensures timely submissions, reports and filings to meet FDA’s regulatory requirements
  • Manages the Quality Systems Specialist position to ensure quality system compliance with all state and federal regulations, to include the hiring process and performance appraisal
  • Responsible for regulatory guidance to the division’s product development teams
  • Responsible for regulatory submissions of FDA pre-market notification and 510(k)
  • Responsible for regulatory reports of MDR (Medical Device Reporting) and Baseline Reporting to the FDA
  • Monitors and audits GMP (Good Manufacturing Practice) and cGMP (current GMP) policy and procedures
  • Maintains correspondence and other records of all interactions with the FDA CDRH, FDA LA District Office and State of California – Health and Human Services. Coordinates and direct strategy and conduct all meetings with the FDA, and regular interaction with the FDA
  • Requires a bachelor's degree in a relevant field or equivalent experience
  • Minimum of 7 years of relevant industry experience
  • This position requires superior verbal and written communication skills and negotiating skills, and the ability to ensure that the division adheres to the FDA quality and regulatory guidelines

Compliance & Regulatory Affairs Quality Assurance Resume Examples & Samples

  • Working with multi-departmental teams in analyzing complex cross departmental issues (Front Office, Operations, Risk Control, Product Control, Finance, GC, Compliance and IT) identifying inefficiencies, control weaknesses and constraints from on-boarding, trade capture/business event management, risk through to settlements, P&L validation, price testing, financial control and regulatory reporting
  • Analyze and suggest improvements to F2B flows with an emphasis on understanding risks and issues along the following dimensions
  • Strong cross business product knowledge; Retail banking, HNW and UHNW Banking products, Securities, FX, OTC Derivatives, Equities, Credit, Rates and commodities
  • Technically strong in the following programmes – Excel, Powerpoint. Sharepoint, Macro/VBA, Xcelsius would be an advantage but not a necessity
  • Business Analysis; the ability to breakdown and understand a problem or process and provide a solution displayed in a presentation also including high level architecture and mapping
  • Project management: leading a project, managing key stakeholders, build relationships across the Bank with FO, PC, Risk, Ops, FA, Reg and IT
  • Solid business understanding across the bank including the Front to Back processes for various products including how the various functions fit against each other
  • Deep knowledge of the full trading lifecycle, business events and reporting
  • Strong market knowledge required, the candidate should have a view of the key dimensions in the current financial market
  • The ability to support control model analysis
  • Experience in target architecture and process improvement delivery, with IT components / IT architecture
  • Strong academic background, ideally post graduate business/technology or equivalent
  • Strong understanding of business process and technology in a major institution Banking
  • OE Black Belt Qualification desireable

Compliance & Regulatory Affairs Resume Examples & Samples

  • Involved in the overall daily operating activities for the function, including managing all human capital processes, e.g., oversight over recruiting processes, coordinating training activities for the function, in partnership with Talent Development, ensuring mandatory training requirements are met, and the MyPerformance.process is completed in a timely manner
  • Ensure that MICOS supervisory controls are completed across the CCRO COO functions supported
  • Support with the day-to-day financial management activities across the CCRO COO functions you support, including: forecasting of financials and headcount, tracking financial and headcount actuals against budgets, cost center ownership and sign-off, maintaining the GAD approval matrix, processing of vendor invoices, raising POs, overseeing and coordinating vendor contracts, working in partnership with Non-IT Sourcing,
  • Implement, drive and track cost efficiency initiatives across the CCRO COO function you support, e.g., OnePC per person, personal communications initiatives (BlackBerries,mobiles), etc
  • Support and implement the workspace strategy for the CCRO COO functions you support
  • Serve as the BCM coordinator for your location
  • Coordinate and provide all updates to outsourcing inventories, RRP critical service matrices, etc. Manage
  • Organize CCRO COO meetings for the functions you support, e.g., team meetings, town halls. This includes: setting the agenda, determining discussion topics; and, preparing discussion materials
  • Contribute, prepare and/or review discussion materials in a timely manner and with high quality for meetings led by or with the CCRO COO
  • Coordinate all changes in the organizational structure for CCRO COO, ensure that changes are reflected in all organizational charts or governance documents, Implement changes in approval flows in downstream systems to reflect organizational changes, accordingly
  • Manage communications activities, in partnership with Corporate Communications and CCRO COO Business Manager, for the functions you support including writing and editing communications, proper syndication of all communications to ensure that stakeholders are aware of and agree to the content of the communications, publishing and distribution; coordinate updates to intranet sites of the CCRO COO functions you support, as required
  • Support the CCRO COO Business Manager on various strategic initiatives for the CCRO COO function
  • Use appropriate governance within area of responsibility, i.e., regular management meetings (incl. minutes and action trackers), controls and procedures to escalate and resolve Supervisory Issues
  • Ensure that all areas in CCRO COO have supervisory protocols for new employees, employees whose job responsibilities change, and employees who leave are in place
  • Retain, direct, motivate and develop staff in order to reasonably ensure that employees under their supervision are competent to perform their functions and receive appropriate training
  • Plan and utilize resources proactively and efficiently
  • Responsible for delivery and management to assigned budget for CCRO COO as well as CRA division
  • Ensure that areas under management operate without significant operational, financial or reputational risks by performing the necessary control tasks
  • Ensure that all information produced by CCRO COO for regulators are updated, reviewed and archived, appropriately
  • 7-10 years of experience in a similar position within a bank or financial services institution; experience working in a strategic management consultancy; knowledge and network in Credit Suisse is a distinct advantage
  • Strong analytical and quantitative skills; likes working with numbers; some accounting / controlling knowledge an advantage
  • Team player who is flexible; able to thrive in a fast changing environment where there is an opportunity to perform a wide variety of tasks at all levels
  • Attention to detail is a must; focus on delivery of a high quality work product in a timely manne
  • Good organizational and communication skills
  • Ability to manage own time effectively, work independently but know when to seek guidance, and take accountability for actions
  • A self-starter and fast learner with creative problem-solving skills
  • High integrity and ability to maintain confidentiality at all times
  • Very good knowledge of Excel, PowerPoint and MS Word
  • Strong written/spoken English language skills
  • A university degree or equilvalent

Regulatory Affairs Resume Examples & Samples

  • Manage all aspects of Document Control
  • Provides regulatory expertise in regulatory labeling requirements
  • Ensure that all Design History projects comply with regulatory, developer, and company requirements for HS products
  • Provide regulatory and compliance interpretations to Marketing and Sales on labeling issues
  • Assists in training staff on pertinent regulatory and pertinent issues, as assigned by department senior staff. Topics include inspections, document compliance, etc
  • Conducts and/or participates in specialized audits, i.e.: documentation, integration, CAPA, procedure manuals, labeling, etc
  • Coordinates department annual records retention projects to ensure compliance with regulatory requirements
  • Conducts product inspections, i.e.: receiving and integration with department administrative staff
  • Participates in CINC Compliance meetings
  • Participates in company Quality Management Review meetings
  • Assists department and senior management and participates in regulatory investigations. Participation includes, but is not limited to: answering questions on documentation, taking inspection notes with Inspection Coordinator, identification of relevant inspection documents, etc
  • Assists with Complaint integrations into Complaint database
  • Initiates and/or assists with trending of documentation metrics for company Management Review and additional meeting forums
  • Education: Bachelor’s required. Preferably in science or healthcare discipline
  • Experience Required: 0-2 years in a medical/pharmaceutical company preferably with responsibility for documentation compliance
  • Excellent understanding of documentation (good documentation practices) required in a medical device/pharmaceutical environment
  • Excellent communication skills, both orally and in writing
  • Experience interfacing with regulatory agencies, i.e., FDA is highly desirable
  • Ability to provide routine trending on documentation projects, as required

VP Government & Regulatory Affairs Resume Examples & Samples

  • Oversees state legislative government and regulatory affairs activity for all states in assigned area(s) and is responsible for securing and maintaining franchise operating authority
  • Collaborates with senior management and State Government Affairs personnel to develop and implement strategies that shape public policy regarding proposed legislative and regulatory initiatives
  • Sets strategic direction and overall guidelines for franchise renewals, including financial calculations and parameters for renewals. Serves as escalation point for issues for complex and/or difficult franchise renewals, franchise transfers, and franchise non- compliance issues
  • Drafts, analyzes, and/or presents legislation, amendments, and testimony as necessary
  • Monitors state legislative and regulatory activities affecting Company and the cable industry
  • Provides leadership and supervision to the Government and Regulatory professional team, including staffing, performance management, compensation administration, office management, etc

Executive Director Product Safety & Regulatory Affairs Resume Examples & Samples

  • Build a Regulatory and Compliance practice for NewAvon which ensures all NewAvon products have met all product safety and regulatory requirements
  • Develop strategies to ensure timely compliance with all emerging federal and state ingredient/product regulations; monitor same and actively participate in commercial associations involved in monitoring/structuring regulations to get early warning of potential issues. Active NewAvon member of the PCPC
  • Ensure all product registrations and notifications are filed in line with regulations (voluntary and mandatory)
  • Approve product labeling and review/approve claim substantiation with Legal
  • Provide direction on compliance issues including FDA/USDA/Canadian customs inquiries detentions and ingredient non-conformance (eg., out of spec)
  • Significant experience in managing regulatory and compliance issues across categories in personal care (focus on skincare a plus); broad knowledge of the science and chemistry of beauty products
  • Consciously aware of trends in regulatory environment for beauty, personal care and nutrition; has experience in similarly regulated markets with a working knowledge of compliance requirements
  • Understanding of FDA/USDA/Canadian customs requirements, product registrations, and notification requirements
  • Familiarity with the legal restrictions around claims substantiation and product labelling
  • Strategic thinker – able to bridge the gap between tactical daily delivery of regulatory compliance and developing a market leading, brand enhancing, product safety practice
  • Demonstrated ability to work closely with Legal, Marketing, Sourcing in assessing risks involved with claims substantiation and new materials
  • Focused and organized
  • Must have led similar function before with proven track record for delivering outstanding results
  • Experience in several aspects of consumer goods, beauty/cosmetics, and/or health and wellness
  • Ability to take full ownership of complex regulatory issues; understands the nuances of working with a restructured organization; strong program management skills a plus
  • Track record of successfully resolving product safety or compliance issues
  • Ability to communicate complex regulatory/compliance issues effectively to a variety of stakeholders
  • Self starter, able to work independently and take the initiative
  • Strong leadership, mentoring and collaborative skills
  • Experience with Canadian regulatory awareness and business environment a plus

Paralegal, Insurance Regulatory Affairs Resume Examples & Samples

  • Serve as primary paralegal to Insurance Regulatory Affairs attorneys and, as needed, to rest of the Regulatory Affairs and Strategy group
  • Monitor regulatory developments that apply to and affect business operations of the firm
  • Track proposed and final rule changes, regulatory guidance and other significant regulatory events/matters and assist attorneys with preparation of regulatory reports
  • Establish and maintain a repository of information on rules, regulations and other regulatory guidance that impact business operations
  • Establish and maintain a repository of key regulatory contacts and pending and closed matters
  • Track and coordinate responses to regulatory requests and inquiries
  • Assist with preparation and submission of filings with state insurance regulators
  • Provide support, review and organize information and documents for financial and market conduct examinations
  • Assist with research and recommendations for internal partners regarding regulatory inquiries
  • Additional duties as assigned
  • Minimum of 3 years’ paralegal experience in a professional services organization, or financial services organization or law firm is required
  • Ability to conduct basic legal research and draft responses regarding regulatory inquiries is required
  • Bachelor’s Degree is preferred; Paralegal certification strongly preferred
  • Experience with life insurance issues and/or financial services regulation strongly preferred
  • Experience drafting regulatory filings and maintaining compliance records preferred
  • Experience tracking proposed regulations, guidance, circular letters, etc., preferred
  • Proficiency in MS Excel, Outlook, PowerPoint, and Word
  • Strong organizational skills, including database management
  • Attention to detail and ability to organize and prioritize tasks

Corporate Office of Regulatory Affairs Executive Administrative Assistant Resume Examples & Samples

  • Assist regulatory policy professionals including calendar and contact management, travel, phone coverage, meeting set up, and ad hoc projects
  • Schedule meetings with senior level internal and external stakeholders (including regulators and policymakers), which may involve numerous time zones
  • Work effectively with other administrative assistants to coordinate/plan meetings, conference calls and conferences, and manage the use of the visitors office
  • Review markups and input revisions to Word and PowerPoint documents
  • Format PowerPoint documents
  • Book international and domestic travel arrangements, and organize itineraries
  • Submit and manage technology requests (arranging purchase and installation of technology, troubleshooting technology issues) and obtain supplies
  • Assist with staff onboarding and off boarding, which includes requesting equipment setup and system access
  • Provide backup support as needed/requested for other executive assistants on the team
  • Ability to work effectively in pressured environment and partner effectively with peers who cover team members in the ORA's other locations, in support of team goals
  • Exhibits a positive, common sense, constructive attitude with character to drive schedules and help manage time effectively
  • Proven technology skills and highly proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook)
  • Strong communication style and good judgment
  • Is flexible, willing and open to challenges and changes
  • Can follow up effectively without prompting and keep one step ahead of arrangements and requirements
  • Anticipates needs
  • High level of attention to detail and delivers high quality results
  • Ability to navigate core technology systems, such as expense and procurement, requisitions, etc
  • Experience interacting with government and regulatory officials, both domestically and internationally

Regulatory Affairs Coverage Officer Resume Examples & Samples

  • Regulatory affairs liaison between key U.S. regulators, primarily the Federal Reserve Bank of New York (FRBNY) Onsite Team and the SEC, and key departments within Credit Suisse
  • Mandate focuses on relationship management (internal and external) and includes managing day-to-day interactions and requests between Credit Suisse and the FRBNY Onsite Team and SEC including facilitating prompt response to questions, assuring delivery of ongoing information, planning and recording management meetings, supporting ‘point in time’ examinations, tracking and reporting interactions and prompt resolution of issues
  • Excellent interpersonal and communication (written and verbal) skills
  • Exceptional comprehension skills and acute attention to detail
  • The ability to work with varying levels of management and with varying levels of expertise
  • Highly proficient in Microsoft Office
  • Proactive self-starter        

Director, Scientific & Regulatory Affairs Resume Examples & Samples

  • Provide thought leadership and strategic oversight for compliance of new products, ingredients, labelling and claims across the CCNA product portfolio for Global Marketing, R&D and other functions. Influence the new product pipeline and M&A opportunities, and develop solutions to minimize regulatory barriers
  • Partner with the business to identify regulatory needs to meet current and future needs, and develop and execute strategies to create a regulatory environment that provides flexibility to the business
  • Provide expertise to guide the business in finding solutions to regulatory compliance issues that affect our products, packaging, ingredient, labelling and claims
  • Maintain a strong network of experts, government agencies, industry peers and other stakeholders needed to maintain a favourable regulatory environment for the company. Represent the company externally on relevant trade and scientific organizations
  • Proactively inform the leadership of emerging regulatory issues of impact to the business and identify strategies to address them
  • Identify and implement best practices that drive efficiency and accuracy of SRA compliance processes
  • Direct the activities of the SRA compliance team and provide leadership and motivation including coaching and mentoring team members
  • Advanced Regulatory Knowledge: Expert knowledge of the food regulatory and political landscape (e.g., regulations, issues, federal/state/local government responsibilities and interactions) affecting food and beverages globally. It includes the ability to manage complex regulatory issues affecting products, ingredients, packages or claims
  • Basic Toxicology: Knowledge of basic beverage ingredient safety
  • Consulting: Ability to provide timely, specific information, guidance and recommendations to help groups, managers and others make informed committed decisions that lead to sustainable impact
  • Food Law: Knowledge of food law as it applies to ingredients and packaging. This includes knowledge of required/allowed levels and restrictions for ingredients or knowledge of where this information exists and how to access it
  • Food Science: Knowledge of principles and techniques of basic food science and their application to the beverage industry
  • Nutrition: Knowledge of basic nutrition concepts and definitions involved in basic nutritional labeling
  • Process Improvement: Ability to analyse existing processes and identify more efficient ways to accomplish goals and meet customer and client requirements; ability to continuously improve processes through regular assessment and adjustment
  • Scientific & Regulatory Affairs expertise: A subject matter expert in regulatory affairs with good understanding on regulations on food labeling, global nutrition policies and action plans. General knowledge of beverage ingredients and manufacturing and food industry. Ability to advocate company positions and to bring solutions to address regulatory risks
  • Technical and Ingredient Policies: Expert level knowledge of Company policies affecting ingredients, product composition, labels and/or technical claims
  • Strategic Direction: Ability to create a clear view of destination for the functional area, help others understand how and why things will be different when destination is achieved, build commitment and inspire action toward the destination
  • Successful Team Leadership: Ability to use appropriate methods and a flexible interpersonal style to build a cohesive team and facilitate completion of team goals
  • Management of the Performance of Others: Ability to plan and support the contributions of individuals and the development of their skills and abilities so they can fulfill current or future job/role responsibilities more effectively
  • 12-15 years’ experience (preferably directing food regulatory compliance programs); leadership skills and people management experience

Labelling & Regulatory Affairs Admin Resume Examples & Samples

  • Bachelor of Science or related fields
  • Experience in Regulatory Affair, import, cosmetics, food or consumer products is preferred
  • Excellent MS Excel skills (V lookup, Pivot table)
  • Able to work under pressure and manage time efficiently
  • Pro-active, highly organized and attention to details

Japan Compliance & Regulatory Affairs Division Control Room Compliance Officer Resume Examples & Samples

  • Maintain Watch and Restricted Lists
  • Review Equity Research for compliance with quiet periods (e.g., IPO, Secondary, and Lock-Up expirations)
  • Conduct compliance training to relevant divisions
  • Look to continuously improve the Control Room operations identify risks and contribute to the efficiency and effectiveness of the function

Japan Compliance & Regulatory Affairs Division Monitoring Resume Examples & Samples

  • Conduct electronic (email, Bloomberg, telephone) surveillance according to a structured program over the activities of defined business areas
  • Escalate, review and ensure appropriate follow up and documentation of potential red flags/ irregular findings
  • Maintain Japan manuals and procedures in relation to the MSA function
  • Support the regional MSA team as required
  • Look to continuously improve the surveillance program, identify risks and contribute to the efficiency and effectiveness of the MSA function

Japan Compliance & Regulatory Affairs Division Private Bank Compliance Officer Resume Examples & Samples

  • Provide pro-active compliance oversight and support for the Private Banking business
  • Look to continuously enhance the Private Banking business compliance control framework and processes
  • Provide advice to the business on regulatory/ compliance issues with respect to launch, offering, structuring and distribution of all asset classes and services (with a particular focus on funds)
  • Conducting proactive monitoring over the activities of the business first line of defense functions as well as conducting routine surveillance and reviews
  • Review and approve product / service related materials such as marketing materials, term sheets, presentations and product brochures
  • Draft and promulgate policies on product compliance, suitability, selling practices, risk disclosures etc
  • Backup other team members and provide support to the team if required

Japan Compliance & Regulatory Affairs Division Financial Crime Compliance Officer Resume Examples & Samples

  • Review new account opening applications to ensure that documentation is complete, and know your client due diligence standards have been met. Further, to conduct screening and anti-social forces checks on all connected parties
  • Policies and Procedures: Ensure that all AML relevant legislative and regulatory changes are duly captured and incorporated into local policies and procedures
  • Look to continuously enhance the AML program and related compliance control framework and processes
  • Conduct training and contribute to periodic risk assessments and other internal reviews and processes
  • Backup other team members and provide support to the team if required

Japan Compliance & Regulatory Affairs Division Financial Crime Compliance Officer Resume Examples & Samples

  • Head of Japan Financial Crime Compliance function, managing a small team of people
  • AML Advisory: Provide AML compliance advice to the business and support functions on AML and CFT laws, rules and regulations as well as CS policies
  • Oversee Suspicious Transaction Reporting framework and AML monitoring program
  • Sanctions Risk Assessment: Ensure sanction risks including those escalated through payment filters are appropriated managed
  • Look to continuously enhance the AML/ CFT program and related compliance control framework and processes

VP Government & Regulatory Affairs Resume Examples & Samples

  • Provide guidance and support at all levels of Comcast management to ensure consistent and sound government and regulatory policy; as well as ensuring compliance with local, state and federal requirements and mandates in the Great Boston Region
  • Sets strategic direction and overall guidelines for franchise renewals, including financial calculations and parameters for renewals. Serves as escalation point for issues for complex and/or difficult franchise renewals, franchise transfers, and franchise non-compliance issues
  • Keep abreast of regulatory affairs activities of communications companies, outside groups and utilities in order to identify issues relevant to the company
  • Develop and maintain positive relationships and collaborations with key government representatives and regulators at the Federal, State and Local level, as well as key stakeholders
  • Lead teams that will help educate elected officials and the community at large as to Comcast strategies and new product and services
  • Coordination with Division and Corporate leads on other regulatory matters involving Comcast
  • Oversee all franchise renewals including managing.. efforts to ensure compliance with franchise obligations
  • Oversee team that maintains relationships with municipalities and monitor involvement of municipal consultants if needed
  • Oversee and lead all community investment initiatives for the region
  • Manage community investment budget
  • Development of long-term grassroots strategy to support Comcast's business priorities
  • Lead team that will promote Comcast's economic and community investments in the Greater Boston Region
  • Oversee Internet Essentials initiatives in GBR to ensure growth for the program
  • Actively seek relief of burdensome franchise obligations
  • Establish oneself as a trusted advisor to regional leadership
  • Represents internally and externally as a member of the Senior Leadership team

Corporate & Investment Bank Office of Regulatory Affairs Executive Director Resume Examples & Samples

  • Input and advice to senior executives in connection with regulatory projects, communications or other initiatives:Partner with the Compliance Regulatory Management team to identify significant interactions or trends in supervisory dialogue, and advise on appropriate strategies to anticipate and respond to emerging regulatory priorities. In particular, to support and promote the development of a coordinated approach to contact with regional regulators ex-UK
  • Quality assurance: Participate in regional and firmwide processes that are designed to ensure regulatory remediation projects are executed to a high standard and fulfil the letter and spirit of regulatory requirements. Work with lines of business and functions to develop remediation plans that are proportionate, achievable and meet these regulatory requirements
  • Governance:Working with the regional governance team within ORA and the Office of the Secretary, ensure relevant regulatory issues are escalated and communicated effectively to senior governance forums, including legal entity boards and regional management committees. Participate in other regional governance forums to identify emerging issues that may require dialogue or additional disclosure to regulators in EMEA
  • Project management:On an ad hoc basis, initiate, design and/or execute projects to meet specific regulatory requirements. These will typically be projects of strategic importance to the firm, may involve innovative or complex concepts, and/or relate to issues that cut across multiple lines of business or functions
  • Policy advocacy: On select policy initiatives that have elevated strategic importance to the Bank, work with ORA to evaluate the practical impact of these measures on the firm, and support ORA in advocacy efforts to enable regulators to meet their intended objectives and minimize unintended outcomes
  • 7-10 years experience in regulation, whether working for a regulator or Compliance, with preferably a strong background in supervisory practices at the UK and other leading EU regulators
  • Strong fluency in either of prudential or conduct regulation, with sound familiarity with the other
  • Ease working across a range of complex issues; ability to learn new topics quickly, courage to ask questions
  • Ability to effectively engage senior leaders around the firm
  • Ability to clearly communicate and present information both orally and in writing

Regulatory Affairs Project Leader Resume Examples & Samples

  • Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches
  • Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers
  • Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
  • Defines data and information needed for regulatory approvals
  • Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
  • Provide Regulatory Affairs support during internal and external audits
  • Plans schedules for regulatory deliverables on a project and monitors project through completion
  • Assists in the development of best practices for Regulatory Affairs processes
  • Represents Regulatory Affairs on cross-functional project teams
  • Partners with other functions to define and obtain data to assist with regulatory submissions
  • Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products
  • Integrates and executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Takes accountability for the achievement of business goals and objectives
  • Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (especially EU)
  • Ability to partner and influence key stakeholders on NPD and Lifecycle teams
  • Clearly defines and prioritizes decision criteria and considers benefits, risks, and Credo of each alternative before making decisions. Considers all of the available facts when situations are ambiguous in order to make the best possible decision (for example, when regulations are unclear)
  • Consistently manages large amounts of changing, complex, and/or ambiguous information from multiple sources and makes timely and effective decisions for the execution of project objectives
  • Knowledgeable in US, EU and International Regulations
  • BS with demonstrable industry experience or equivalent
  • Practical experience with the preparation and submissions for Class II and III medical devices
  • Knowledge of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred

Senior Officer Regulatory Affairs Nicotine Resume Examples & Samples

  • Provide regulatory guidance on NCPs in the markets of interest, as well as support local markets in the region in terms of submissions and enquiries from regulatory authorities
  • Participate in regulated cross-functional activities related to NCPs, including but not limited to: risk management, change management, labelling management, and post-marketing surveillance
  • Ensure the timely and accurate preparation, compilation, review and publishing of NCP regulatory dossiers in compliance with local regulatory requirements and PMI’s internal standards, in support of clinical studies, market-specific regulatory engagement activities, and marketing authorizations
  • Stay abreast of current and new legislation in the European Union. Follow and analyze the applicable regulatory requirements to provide input on all regulatory aspects of relevance
  • Contribute to the development and implementation of processes, systems and tools enabling effective regulatory documentation/content management
  • Establish strong relationships within RRP in order to ensure alignment between regulatory strategies, product development and assessment plans, and business goals

Senior Officer Regulatory Affairs Heated Tobacco Products Resume Examples & Samples

  • Work in coordination with the Manager Regulatory Affairs HTP to define and implement registration activities for PMI's Heated Tobacco Products (HTP) in defined region, according to PMI's development and launch plan
  • Be responsible for preparation, compilation, quality & scientific check and publishing of RRPs submissions for HTPs in compliance with regulatory guidance/requirements in the defined region and PMI internal standards. Ensure completeness and accuracy of submissions to regulatory authorities in support of assessment studies, market-specific regulatory engagement activities and existing marketing authorizations
  • Ensure compliance and maintenance of all product registrations for PMI's HTPs in the defined region throughout the whole life-cycle of the products
  • Stay abreast of current and new legislation in the defined region. Follow and analyze the applicable regulatory requirements in the region and contribute to the implementation of submission plans and strategies
  • Provide advice to the organization for all regulatory aspects which are of relevance to PMI's HTPs in the defined region
  • Contribute to the development and implementation of processes, systems and tools enabling effective regulatory documentation/content management and communication with/submission to regulators. Provide input to optimize processes to ensure the development and implementation of electronic systems for effective management of documentation, submissions and archives (Controlled document management system for R&D and Regulatory publishing system and tools)
  • Establish strong relationships within R&D and associated commercialization functions in order to ensure alignments between regulatory strategies, product development & assessment and business goals
  • Reduced Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes. PMI’s RRPs are in various stages of development, and we are conducting extensive and rigorous scientific studies to determine whether we can support claims for such products of reduced exposure to harmful and potentially harmful constituents in smoke, and ultimately claims of reduced disease risk, when compared to smoking combustible cigarettes. Before making any such claims, we will rigorously evaluate the full set of data from the relevant scientific studies to determine whether they substantiate reduced exposure or risk. Any such claims may also be subject to government review and approval, as is the case in the USA today

Regional Head Regulatory Affairs Resume Examples & Samples

  • Develop and lead registration strategies in the region to ensure timely registrations for RRP
  • Develop and lead the registration strategies as required for other novel products in the region
  • Ensure timelines for regulatory clearance for product launches and priorities in the region are met
  • Ensure on-going regulatory product compliance of the RRP portfolio marketed in the region
  • Provide regulatory oversight and support to Product Development and R&D efforts in the development across PMI’s RRP platforms by participating and leading regulatory input into cross-functional project teams
  • Effectively manage relationships with the Regulatory Affairs group within PMI and relationships with regulatory authorities, where necessary, to ensure PMI regulatory applications are strategically aligned with regulators’ expectations
  • Provide leadership to the central Regulatory Affairs function in defining and implementing the registration activities in support of product registrations
  • Recruit and develop and maintain high caliber regulatory professionals to support individual country RA activities
  • Reduced Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes. PMI’s RRPs are in various stages of development, and we are conducting extensive and rigorous scientific studies to determine whether we can support claims for such products of reduced exposure to harmful and potentially harmful constituents in smoke, and ultimately claims of reduced disease risk, when compared to smoking combustible cigarettes. Before making any such claims, we will rigorously evaluate the full set of data from the relevant scientific studies to determine whether they substantiate reduced exposure or risk. Any such claims may also be subject to government review and approval, as is the case in the USA today

Director of Regulatory Affairs Resume Examples & Samples

  • As a member of Global RA Leadership Team, this person will be responsible for understanding and integrating the Diversey Care strategic objectives with the Global RA Service Center and Regional teams work plans. This person is also responsible for ensuring that the necessary skill sets are available or developed within the RA group
  • Participates in division’s strategy meetings, showing ability to identify, assess and communicate regulatory constraints and trends, as well as risks and opportunities while integrating in Division’s strategy, timelines and budgets
  • Leads coordination of compliance projects for the portfolio
  • Identify, assess and ensure agreement on potential risks in division compliance strategy
  • Possesses practical working knowledge of the global regulations that affects Diversey Care. A non-exhaustive list includes: TSCA, EPA Regulated Substances, Cosmetic Products, GHS, CLP, EU BPR, REACH
  • Holds full responsibility in setting priorities and defining resource allocation and requirements, including ad-hoc support by the Global Service Center, and flags any issues early to the RA team and with Division leadership as appropriate
  • Accountable for defining the division’s global advocacy strategy (together with other RA Business Partners) and implementing with Regional Leaders and SMEs; leverage the RA resources to shape a favorable regulatory environment at all levels, showing ability to identify risks and opportunities on a global scale
  • Represents and promotes the company and the division in the global regulatory scenario, through leadership roles in sector’s associations such as the American Cleaning Institution. Also, will actively participate in international conferences
  • Develop insight with Regulatory Authorities, understand trends, effectively participate in wide regulatory strategies
  • Leverage personal and group’s competency to gain insight with key and prospective clients
  • Bachelor’s degree in Chemistry, Chemical Engineering, Microbiology or Science related field
  • Minimum five years’ experience in regulatory affairs, preferably in the chemicals area, with demonstrated successful work history
  • Experience of working in global environment
  • Fluent in the English language, second language preferred
  • Strong communication and interpersonal skills, including solid presentation skills
  • Proficiency in Microsoft Office applications

Scientist Regulatory Affairs Resume Examples & Samples

  • Ensure regulatory compliance of products, labels, advertising and promotions as well as adherence to policies and guidelines
  • Develop nutrition and regulatory technical information for ingredients and products
  • Review/approve label graphics for regulatory compliance and technical accuracy
  • Review advertising and promotional materials for technical accuracy and compliance
  • Provide nutrition and regulatory guidance on project teams to enable accurate decision-making
  • Partner with R&D and business teams to identify opportunities for the brands
  • Stay abreast of nutrition and regulatory developments and identify opportunities and implications to the business
  • Manage and elevate consumer inquiries and support corporate requests

Regulatory Affairs Operations Officer Resume Examples & Samples

  • Working knowledge of theories, principles and concepts typically acquired working in a clinical research setting, academic research, or health care environment related to research administration
  • Understanding of research compliance and Human Research Protection Programs, or research regulations preferred
  • Excellent verbal communication skills and writing skills
  • Demonstrated experience working with multiple internal and external constituencies to build consensus in setting agendas and implementing approaches in large decentralized setting
  • Proactive, time-sensitive, results-driven approach to carrying out assigned and assumed responsibilities, and possess the ability to handle multiple, often competing tasks, with grace and good humor to reach common group goals
  • Flexibility and adaptability to changing priorities
  • Comfort with public speaking
  • Familiarity with REDCap, Qualtrics or other survey tools a plus

Regulatory Affairs & Quality Associate Resume Examples & Samples

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures, including local and international regulations applicable to clinical trials supply chain activities
  • Maintain a good understanding of local and international regulations, and keeping abreast with regulatory changes and developments
  • Provide consultative guidance on regulatory matters to clients and internal associates
  • Responsible for liasons with local and international regulatory bodies
  • Coordinate regulatory and submission activities for the following: importation/exportation of investigational medicinal products (biologicals/controlled substances/psychotropics/cytotoxics)/medical devices, local clinical trial import licences, GMP and GDP Certificates and related approvals/licences
  • Maintain and updates all regulatory licences/certificates/approvals and related regulatory databases
  • To ensure that the inventory of supplies is accurately maintained with supporting documentation
  • Responsible for comparator drugs and ancillaries sourcing
  • Manage and coordinate all recall activities (internal/client initiated/regulatory initiated)
  • Prepare new and update existing job related Standard Operating Procedures (SOPs)
  • Perform pre and post review and approval of production batch records
  • Perform pre and post review and approval of label printing records In-process inspection responsibilities for production and label printing jobs
  • Assist in the QA/GMP training of employees across the company
  • Participate in department systems development initiatives to improve regulatory and quality efficiency and compliance
  • Perform ad-hoc duties as requested by line management
  • Previous working knowledge in the pharmaceutical/medical/healthcare settings in the field of quality assurance and regulatory affairs

Regulatory Affairs Office, Director Resume Examples & Samples

  • End-to-end regulatory exam management, including JFSA and BOJ Proactive open issue tracking (MRA/MRIAs) and issue escalation
  • Regulatory change management and reach-out
  • Manage annual roll-up of MUFG and BTMU by primary regulators
  • Communicate continuously with Tokyo HO stakeholders, including but not limited to BTMU Global Planning Division and MUFG Government and Regulatory Affairs Office
  • Manage and coordinate senior executive communications with regulators
  • Build relationship with all primary regulators at the senior level, including those with DC staff functions
  • At least 10 years’ experience in diverse business roles – e.g., revenue generating roles, program management, audit/compliance, managing staff functions

Regulatory Affairs Leader Resume Examples & Samples

  • Work closely with other professionals across the company to ensure compliance to global regulations and reporting requirements related to post market surveillance
  • Identify complaints that meet the global definition for reporting and facilitate the timely submission of regulatory reports
  • Determine the need for, prepare and, when required, submit regulatory notifications including adverse events, accidental radiation occurrences and notifications of defect or failure to comply
  • Complete reportability assessments
  • Provide input for evaluation of potentially hazardous/potentially reportable complaints; review potentially hazardous complaint files to ensure
  • Bachelor’s Degree & minimum of 3 years experience in the medical device industry or
  • Demonstrated experience operating in a highly regulated environment; proven application of analytic skills in a regulatory environment
  • Knowledge of the FDA’s Quality System Regulations; experience working within a Quality Management System
  • Ability to prioritize, plan & evaluate deliverables to established strategic goals
  • Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
  • Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
  • Strong problem solving, influencing and negotiation skills
  • Ability to work well independently & in a team setting
  • Prior experience using spreadsheet and presentation software
  • Strong working knowledge of Medical Device regulations, such as FDA CFR 21 Parts 820, 803, 806 & 1002/03; ISO 13485; MDD; CMDR
  • Regulatory Affairs Certification (RAPS)
  • Experience with ISO 14971 (Risk Management)
  • Experience with IEC 60601, 2nd Edition (if involved with electro-mechanical equipment)
  • Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL
  • Experience with working across cultures/countries/sites
  • Demonstrated ability to identify, influence and lead process improvements and procedural changes
  • Proven experience in Nuclear Medicine medical devices

Regulatory Affairs & Product Stewardship Manager Resume Examples & Samples

  • Propose regulatory submission strategies and achieve Product Stewardship Chemical Inventory Listing in support of the business strategy
  • Create and maintain Product Stewardship records relating to company products, intermediates and raw materials
  • Responsible for the continuing integration of Product Stewardship into business and R&D processes
  • Responsible for gaining and maintaining agency listings as directed by business management
  • Ensure compliance with global regulations i.e. REACH, GHS, etc
  • Respond to internal and external requests for product safety information on company products
  • Interact extensively with internal and external customers both domestic and international
  • Prepare and revise SDS, labels and other hazard communication information using a SAP
  • Provide broad technical expertise in OSHA, FDA, ISO 10993, and other global substance control regulations
  • Keep abreast of and assess international chemical control laws and pending regulatory developments through reference sources
  • TSCA Coordinator for the business, oversee TSCA compliance, lead investigations regarding TSCA 8c/8e allegations of health and safety issues related to the use of our products or raw materials
  • Special projects and other duties as assigned by management
  • Conduct assessments and ensure proper implementation of Responsible Care for the Product Safety Code and other Solvay Product Stewardship Management Systems
  • Individual contributor and also Manager of the Aromatics Product Stewardship team

Regulatory Affairs & Quality Consulting Manager Resume Examples & Samples

  • 7+ years of experience in regulatory affairs and quality within the medical device industry
  • 7+ years of experience in medical device quality engineering with a background in manufacturing engineering and/or process engineering, ASQ/CQE, preferred
  • Bachelor’s degree in Science, Engineering or related field, preferred
  • Expert knowledge in FDCA, FDA QSR, EU MDD, and ISO 13485 requirements
  • Working knowledge of ISO 14971, IEC 62304 and IEC 60601 series standards, preferred
  • Experience to include but not limited to: QS SOP development, PHA / risk management, and design control best practices to ensure compliant DHF, V&V, DMR transfers, working knowledge of FDA requirements for internal / supplier audits and FDA inspections and continuous improvement methodologies
  • Frequent travel throughout the region, with approximately 75% overnight travel

Regulatory Affairs Operations Coordinator Resume Examples & Samples

  • Manage the Director’s complex calendar and related logistics by triaging a high volume of scheduling, travel arrangements, expense reporting and related logistics to assure the Director and Program meets deadlines and deliverables
  • Assist the Director in developing agendas for high-level meetings and attend meetings as requested to take minutes and capture action items
  • Review, redline, and proofread documents such as reports, agreements and presentations
  • Draft high-level correspondence such as email, and other communications
  • Create PowerPoint presentations with infographics for local and national presentations
  • Collect Program metrics with assistance of the Regulatory Officers
  • Assist the Director and Associate Director in maintaining the Regulatory Internship Program by assisting in assessment and prioritization of administrative tasks, intern tasks, and calendar coordination
  • 3 or more years providing administrative or executive support and project coordination, preferably in the area of research administration, academia, or healthcare
  • College degree preferred or an equivalent of education plus experience in an office environment
  • Successful candidates will have well developed interpersonal and communication skills with experience providing complex administrative support in a high profile, very fluid environment, with tact and diplomacy on a range of issues, many of which are confidential in nature
  • Ability to work with cross-institutional teams and with a variety of special/ongoing projects and diverse constituencies
  • Excellent organizational and writing skills
  • Excellent computer skills, including knowledge of Microsoft Office and Outlook, and PowerPoint
  • Ability to prioritize work in an environment with multiple and conflicting interests
  • Expertise with scheduling/calendaring coordination
  • Paralegal experience a plus

VP, Regulatory Affairs & Compliance Resume Examples & Samples

  • Drive compliance program growth & maturity across US Pharma
  • Lead the compliance program growth & maturity across Regulatory Affairs (other than for controlled substances regulatory compliance matters which is managed by a separate team) and Compliance & Ethics for US Pharma. Identify and leverage synergies across both groups as these two teams will be newly combined
  • Effective training and education, such as policies and procedures
  • Effective lines of communication
  • Internal monitoring and auditing of US Pharma business units operations
  • Compliance risk assessments
  • Effective controls and metrics that enable management to conduct operations in a manner that will meet compliance obligations
  • Work with HR and employee relations teams to ensure well-publicized disciplinary policies and guidelines that will enable management to consistently enforce standards
  • Rapid response process to enable management to respond to detected problems and undertake corrective action
  • Support internal investigations efforts conducted by Global Compliance & Ethics CE team and lead investigations assigned to the BU Compliance teams in response to reports of possible compliance violations, including communication with management to alter operational procedures and/or service/product changes to decrease the likelihood and severity of any future offenses
  • Encourage when appropriate corrective action as a result of internal investigation with all departments, providers, and employees
  • Successfully manage a team of 7 to 8 Regulatory Affairs & Compliance & Ethics professionals
  • Develop a combined function that leverages synergies across both groups
  • Act as the key US Pharma liaison and collaborator with Global Compliance & Ethics and manage the implementation of enterprise-wide compliance initiatives
  • Compliance work experience within a Regulated industry or within the Healthcare industry working with Hospitals, Pharmaceutical Manufacturers and/or Pharmacies
  • Excellent oral and written communications skills, analytical skills and advanced knowledge of the law
  • Practical experience in writing and implementing policies and procedures
  • Strong influencing and partnership skills
  • In depth knowledge of compliance and ethics frameworks and principles, and experience in compliance programs based in US Federal, state, and/or international laws
  • Excellent oral and written presentation skills, including the ability to communicate to all organizational levels
  • Demonstrated excellence in leadership, alignment and execution
  • Demonstrated ability to successfully influence across many organizations at all levels
  • Demonstrated experience in working collaboratively in cross-functional and cross- divisional teams or solving cross-functional/cross-divisional issues in a manner that not only demonstrates both strategic and tactical thinking, but also in a manner that builds, maintains, and enhances a positive working relationship
  • Ability to recruit, train, coach and retain team members
  • Ability to tolerate ambiguity and to remain flexible under pressure

Regulatory Affairs Consultant Medicare & Retirement Resume Examples & Samples

  • Manages and is accountable for own workload
  • Impact of work is most often at the national product level
  • Supports Medicare and Medicaid Product teams’ direction, resolves problems and provides guidance to business partners
  • May oversee work activities of others
  • Adapts departmental plans and priorities to address business and operational challenges
  • Influences or provides input to business product forecasting and planning activities
  • Product or process decisions are most likely to impact multiple groups of employees and/or customers (internal or external)
  • Collaborate with product teams to review, analyze, and develop / oversee initial implementation project plans to support business implementation with new or existing laws and regulations
  • Track and analyze all new regulatory requirements pertaining to Medicare, dual products, Medicare-Medicaid, lines of business
  • Develop knowledge of Medicare STAR Ratings methodology and annual cycle to support business partners in their assessment and implementation plans
  • Develop knowledge of Special Needs Plans Model of Care requirements to support business partners in their annual submissions
  • Develop relationship with the SNP Alliance and share industry information with internal partners
  • Prepare summaries of analysis that include, as appropriate, relevant legislative history, comparisons to existing or proposed legislation in other jurisdictions and detailed descriptions of the operational requirements and affected functions
  • Develop and provide training of regulatory requirement
  • 5+ years of experience in a health care regulatory environment
  • 3+ years project management experience, including experience simultaneously managing multiple projects
  • Working knowledge of Medicare and Medicaid, STARS, CMS guidance on Special Needs Plans
  • 2+ years of experience working with Federal Government Programs
  • Excellent communication skills, verbally and in writing
  • Ability to analyze and problem solve with a high degree of accuracy and attention to detail
  • Managed care, and/or compliance expertise
  • Ability to effectively understand and communicate detailed and complex information verbally with others, including government officials and senior leadership
  • Superior planning and strong problem solving skills that enable quick identification and efficient resolution of issues
  • Highly collaborative individual with ability to influence others and build strong professional relationships

Head of Cosmetics Safety & Regulatory Affairs Scientist Resume Examples & Samples

  • Regulatory strategy and product management relating to EU cosmetic regulation EC 1223/2009
  • Providing scientific advice to clients and colleagues on European and US regulatory requirements
  • Developing and leading a successful team
  • Growing existing client base for cosmetics safety and regulatory affairs including identifying additional business development opportunities
  • Ensuring that projects are delivered to high standards, on time and within agreed budget
  • Producing Product Information Files (PIFs) and Cosmetic Product Safety Reports (CPSRs)
  • Accountable for managing our Responsible Person (RP) duties on behalf of our international clients
  • Minimum of BSc in chemistry, pharmacology, biology, cosmetic science or a closely related field together with experience of working in a technical/regulatory environment
  • A proven track record of managing regulatory data and communicating technical data to a non-technical client base
  • Thorough understanding of the EU and US cosmetic regulations
  • Business development and staff management experience
  • A team player who can lead projects and who works well with colleagues and clients

Analyst, Regulatory Affairs Resume Examples & Samples

  • BCII Regulatory affairs expert – responsible for
  • Compilation of documentation and liaison with Corporate RA & Subcommittees in respect of activities required for
  • Adverse event review and agency reporting
  • Issuing Product Information Notifications/Field Safety Notice/Product Corrective Action letters
  • Device modification proposals for review by Corporate RA
  • Compilation of global regulatory submissions
  • Co-ordination of the licenses for controlled substances and other documentation as required from the Dept. of Health & Children and Dept. of Agriculture
  • Implement regulatory/quality system requirements as per IVD Directive (CE Mark) ISO13485 and FDA QSRs
  • Control of distribution of product from regulatory perspective through regulatory stop ship program
  • Provision of Regulatory affairs advice when requested internally and from interpartners
  • Participation in BCII Internal and External Quality Audit as required
  • Participation in BCII Risk Management & Design Control processes from a regulatory perspective as required
  • Participation in Management Reviews of the Quality & Environment System as required
  • Communication to management on Regulatory affairs issues, which require addressing
  • Approval of Printed material from a regulatory affairs perspective
  • CE Marking – Regulatory requirements (ref. CE Technical Files)
  • Dealing with European Competent Authorities as needed regarding vigilance and registration
  • Will be qualified to a minimum of B.Sc. level in a Scientific field or other relevant technical field
  • Have a minimum of 1 year experience in a QA or RA role within a manufacturing facility
  • Excellent written and communication skills are essential, which will result in strong working relationships cross functionally within BCII
  • Ability to work in a very busy environment, ability to manage change effectively in order to better serve our internal customers, external customers and legislative demands
  • Knowledge and understanding of the IVDD Directive and the associated harmonised standards
  • Knowledge and understanding of ISO13485: 2003 and the FDA QSRs
  • Experience of 510K preparation and submission process for FDA pre-market approvals is desirable
  • Experience of product registration process for countries other than EU and USA is desirable
  • Experience of internal auditing is desirable

Regulatory Affairs Administrator Resume Examples & Samples

  • Compilation of documentation required for global regulatory submissions
  • Compilation of documentation as required by Corporate RA
  • Dealing with regulatory enquiries from inter-partners and internal customers
  • Co-ordination of the licenses for controlled substances and other documentation as required from the Dept. of Health & Children and Dept. of Agriculture
  • Control of distribution of product from regulatory perspective through regulatory stop ship program
  • Participation in BCII Internal and External Quality Audit as required
  • Communication to management on Regulatory affairs issues, which require addressing
  • Approval of Printed material from a regulatory affairs perspective
  • Compilation and update of CE Technical Files
  • Routine departmental office duties including ordering, filing, maintaining logs, issuing reports, etc
  • Good administrative experience
  • Very good knowledge of Microsoft Word and Excel
  • Knowledge of Quality Standards/GMP
  • Third level science qualification, or relevant experience in an FDA regulated environment a distinct advantage

Team Lead Regulatory Affairs Digital Dentistry Resume Examples & Samples

  • Development and execution of regulatory strategies for development projects within the Digital Dentistry business unit
  • Leading the RA team for software and individualized prosthetic development and registration in the early markets (US; EU; CAN, AUS)
  • Responsible for monitoring submissions and timely execution of projects
  • Mentoring the RA team
  • Support of product development in cross functional teams
  • Review and/or approval of documents of the design control process
  • Accountable for regulatory compliance
  • Support international product registration
  • Assessment, approval and regulatory implementation of change requests
  • Review and approval of product related labeling and marketing material
  • Support SAP based reporting systems
  • Develop and maintain standard procedures for RA relevant processes
  • Monitoring legislative environment in relevant markets
  • Training internally on relevant procedures and requirements
  • Technical or scientific background, university degree is an advantage
  • Minimum 5 years experience in Regulatory Affairs within the Medical Device Industry
  • Experience with EU, US, AUS and CAN medical Device regulations
  • Experience in preparation and support of notified body audits and FDA inspections
  • Experience in managing cross functional projects and teams
  • Excellent Knowledge of medical device legislation EU ,US, AUS and CAN and corresponding guidelines
  • Excellent knowledge of product development processes in MD industry
  • In depth knowledge of requirements for software development and registration as Medical Devices (IEC 62304 and ICE 62366) as well as standards for electrical products such as IEC 60601
  • In depth knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
  • Fluent in English (verbal & written), further languages are an advantage
  • Highly organized and able to work under strict time lines
  • Strong interpersonal skills and proactive working attitude in a international matrix organization

Senior Analyst Regulatory Affairs Resume Examples & Samples

  • Represent Global Regulatory Affairs on all matters relating to global processes
  • Manage and maintain UDI labeling project and associated performance metrics
  • Participate in Product Labeling Council with support in developing the meeting agenda and presenting the selected subjects as appropriate
  • Participate in Global Regulatory Council with agenda items, review of new regulations, guidance documents, and standards with ability to conduct impact assessment , present clearly, and gain consensus for decision and adoption as necessary
  • Liaise with the regional and geographical Q&RA organization to support and ensure alignment with BEC global policies and procedures
  • Support the continual growth and development of the Global Product Registration System (Trackwise)
  • Continually develop, monitor and report on the metrics needed to gauge the performance of the Global Product Registration System
  • Review and update as necessary changes to existing processes and SOPs as defined by changes in regulations and standards
  • Support the application of Danaher Business System (DBS) tools throughout Global Regulatory Affairs and drive DBS activity throughout the global processes
  • Review changes to existing products and SOPs to define the requirements for regulatory submissions
  • Maintain current knowledge of FDA and international regulations, guidance documents and standards applicable to company products
  • Actively participate in evaluation of regulatory compliance of document / product /process /test methods changes
  • Participate in research of regulatory issues and dissemination of regulatory information to the various departments and senior management as required
  • Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws
  • Works with minimal guidance and expands knowledge and skill sets beyond own area
  • Supervise Regulatory Affairs consultants and/or interns as required
  • Bachelor’s degree in field with 5+ years of experience or Master’s degree in field with 3+ years exp. Or Doctoral degree with 0-2 years exp
  • Hands-on product registrations experience for the USFDA and ex-US countries strongly preferred

Quality Assurance & Regulatory Affairs Senior Manager Resume Examples & Samples

  • Manage the QRA staff and activities supporting the LBS Companion Diagnostics business
  • Responsibilities include but are not limited to development of regulatory strategies to meet regulatory requirements, project and business goals. Will also manage the organization, planning and compilation of regulatory submissions and associated activities of team
  • Responsible for overseeing the maintenance and compliance of the LBS Companion Diagnostics quality system in the Danvers, MA facility. Also responsible for ensuring all CDx projects are aligned with the quality systems of other LBS locations and third parties, as applicable
  • Work closely with members of LBS global regulatory team to coordinate the development of regulatory strategies to meet business needs. As needed, manage or support the creation and submission of international filings
  • Responsible for managing staff performance and development according to Danaher standards and local practices
  • Serve as a contact with the US FDA and other government officials while representing LBS for submission reviews, face-to-face meetings, teleconferences and written communications
  • Serve as official QRA management representative for LBS Danvers location
  • Serve as a contact with pharmaceutical companies representing LBS QRA interests and requirements on CDx projects. Will also represent LBS QRA during capabilities presentations and other activities related to gaining CDx business
  • Manage QRA timelines, budgets and resource allocation according to requirements of CDx business team
  • Use Danaher Business System (DBS) tools to lead team and QRA function in continuous improvement initiatives
  • Bachelor’s degree in life science, medical or biotechnology field and relevant experience with increasing responsibility in medical device regulatory affairs, or
  • Graduate degree in life science, medical or biotechnology field and relevant experience with increasing responsibility in medical device regulatory affairs
  • Related experience includes relevant people management experience
  • Experience in the IVD field preferred and CDx experience very beneficial
  • Must have requisite training or certification in medical device regulatory affairs through on-the-job training, seminars, training. RAC certification preferred
  • Must have experience managing medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485. Quality system or auditing certifications highly desirable
  • Experience with successful clearance and/or approval of US FDA medical device submissions (e.g. 510k, PMA, BLA)
  • In-depth knowledge of global medical device regulations in established and high growth markets (e.g. US FDA, IVDD, Japan, China, Brazil)

Regulatory Affairs Esubmission Manager Resume Examples & Samples

  • Support the development of compliant regulatory electronic/IT systems
  • Liaise with global and country Regulatory Managers on how to build and maintain electronic submissions
  • Work with the Regulatory Agencies and Regulatory Affairs authors to ensure that documents comply with regulatory and company guidance specifications
  • Work with all departments to implement, maintain and train processes and quality control checks to ensure electronic submissions are complete and meet technical, eCTD regulatory requirements, guidelines, internal standards and timelines
  • Assess the impact of eCTD-related software upgrades and changes. Interface with IT and other regulatory departments to ensure a smooth transition and perform trainings to other users as applicable
  • Maintain regulatory archiving systems and regulatory databases
  • Be updated on ICH/ROW specifications and specific national regulatory esubmission guidance and legislation
  • Education: University degree (min. Bachelor) in either IT, economical or in natural science such as pharmacy, biology, chemistry
  • Languages: English (fluent) / German (basics)
  • Personality & Experience: High affinity for IT systems and willingness to acquire specific knowledge about electronic transfer and technical requirements within regulatory affairs within the pharmaceutical industry. (Ideally) experience in Regulatory Operations with a focus on electronic submissions and/or understanding of different functional document types that comprise regulatory submissions. Sound organizing skills and ability to handle several activities at the same time; Ideally experience in either IT-Management/Projects or within Regulatory Affairs; Good leadership and training skills for leading crossfunctional teams

Specialist, Regulatory Affairs Resume Examples & Samples

  • Under direct supervision of the RA Project Manager, or Department Manager, assists in preparing moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, IDES, IDE Progress Report, Clinical Trial Submission [OUS], 510(k), PMA, PMA Annual Report, Shonin, PLA, CE-Mark Design Dossier, CEMark Technical File, Intercontinental Dossiers, Certificates to Foreign Government
  • Ensures that existing approvals and documentation are maintained, including SAP Foreign Trade Status. Communicates with in-country RA personnel to facilitate global clearances/approvals
  • Under the direct supervision of RA Project Manager or RA Department Manager, develops global regulatory strategies for project teams
  • Provides input on and reviews protocols and reports for: design verification, design validation, shelf life, pre-clinical studies, and clinical studies
  • Monitors, researches and obtains information [via FOI] on FDA clearances/approvals of competitors, and proactively shares this information with interested parties
  • Communicates with regulatory agencies under direct supervision of the RA Project Manager or RA Department Manager
  • Assume regulatory review of labeling content, product and process changes and product documentation
  • Excellent writing and verbal communication skills and experience working on cross-functional project teams
  • Basic working knowledge of all U.S. regulations that affect Class II devices
  • Basic understanding of global regulations
  • Strong problem-solving and analytical ability
  • Familiarity with new product development systems
  • Required computer skills include intermediate to advanced Microsoft Word and beginning to intermediate Microsoft Excel
  • Comfortable working in a variety of corporate business management computer systems
  • A Bachelor of Science degree in a scientific or engineering discipline is required; a Masters degree preferred

Regulatory Affairs & Quality Assurance Supervisor Resume Examples & Samples

  • 3+ yrs experience in Regulatory Affairs & Quality Assurance
  • Working experience of country regulatory affairs regulations and processes
  • Working experience in Class III & IV submissions
  • Advanced proficiency in English and required (reading, writing and speaking)
  • Strong proficiency in MS Office, including PowerPoint, Excel, Word and Outlook
  • Excellent organizational skills and demonstrated ability to handle multiple tasks accurately and efficiently
  • Prior experience in fast-paced office with multiple priorities
  • Must be customer service oriented with strong interpersonal skills
  • Excellent presentations skills
  • Responsive, action-oriented and innovative problem solver
  • Experience preparing international product registration dossiers
  • Experience compiling technical files
  • Regulatory/clinical/product development/ quality experience

Regulatory Affairs Consultant Resume Examples & Samples

  • Undergraduate degree
  • 3+ years of experience in a legal or regulatory environment
  • Proficiency with MS Office (i.e. Excel, PowerPoint, etc.)
  • Healthcare regulatory environment and/or managed care experience

Quality Assurance / Regulatory Affairs Intern Resume Examples & Samples

  • Completed at least one year of college education before beginning internship
  • Must be enrolled in school the semester following your internship
  • Pursuing a Bachelors or Masters Degree
  • Authorized to work in the United States without requiring sponsorship
  • Must be geographically mobile
  • Strong academic performance (GPA = 3.0/4.0)
  • Exceptionally demonstrated interpersonal skills
  • Demonstrated oral and written communication skills
  • Quality: Pursuing Biology, Biochemistry, Chemistry, Bioengineering Degree

Regulatory Affairs Advertising & Promotion Manager Resume Examples & Samples

  • Regulatory history, guidelines, policies, standards, practices, requirements and precedents
  • Regulatory agency structure, processes and key personnel
  • Principles and requirements of applicable product laws
  • Submission/registration types and requirements
  • Good practices (GxP's)
  • Principles and requirements of promotion, advertising and labeling
  • International treaties and regional, national, local and territorial trade requirements, agreements and considerations
  • Domestic and international regulatory guidelines, policies and regulations
  • Ethical guidelines of the regulatory profession, clinical research and regulatory proces

Contract Role-regulatory Affairs Resume Examples & Samples

  • BA/BS degree in a scientific/health sciences discipline
  • 5 years of experience in regulatory affairs in the pharmaceutical/biotech industry
  • Solid understanding of the processes and interactions essential for the production of regulatory submissions
  • Experience with US and ex-US regulatory submissions, including: eCTD, IND, CTA, NDA, orphan drug, fast track, SPA and additional submission types
  • Must be “hands-on” and willing and expected to take on projects and tasks to support the team
  • Able to implement and manage projects

Manager of CMC Regulatory Affairs Resume Examples & Samples

  • Planning and preparing CMC documentation for U.S. IND submissions, amendments, and annual reports
  • Planning and preparing CMC documentation for CTA submissions and amendments for Canada, Europe and other countries
  • Reviewing IND/CTA CMC documents including response to inquiries from health authorities, and preparing them if necessary
  • Collaborating with AIRM contract manufacturing organization(s) on CMC related matters
  • Participating in planning (including document authoring and review) and execution (including attendance, if appropriate) of FDA meetings on AIRM projects, and providing support for these regulatory activities
  • Providing guidance and support to AIRM staff regarding global CMC regulatory matters
  • Establishing, promoting, enhancing and maintaining effective collaborations in global CMC activities among AIRM, Astellas-US, Astellas-EU and API
  • Supporting the update or creation of regulatory affairs SOPs
  • Obtaining appropriate information and advice from outside consultant(s) for creating CMC regulatory strategy both general and to address specific topics
  • Researching and disseminating regulatory intelligence on trends in US regulatory affairs in the CMC area for biologics and industry standards for CMC regulatory work
  • Participating in AIRM and Astellas Development meetings, as appropriate
  • Bachelor's degree in Life Sciences
  • A minimum of 5+ years experience in regulatory affairs and other relevant experience in pharmaceutical development of investigational stage drug/biologic products
  • Adequate knowledge of US, Canada and EU CMC regulations as well as ICH and US guidance documents related to CMC matters and strong knowledge of process, formulation or analytical chemistry