Manager, Regulatory Compliance Resume Samples

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FF
F Ferry
Foster
Ferry
20480 Rene Pines
Houston
TX
+1 (555) 347 1764
20480 Rene Pines
Houston
TX
Phone
p +1 (555) 347 1764
Experience Experience
New York, NY
Manager Regulatory Compliance
New York, NY
Bosco Inc
New York, NY
Manager Regulatory Compliance
  • Monitor for regulatory updates, including new forms, interpretations, legislation and case law
  • Implements monitoring programs to ensure compliance
  • Provides assistance in the development and maintenance of supporting policies, procedures, agreements, and contracts
  • Assist with the Compliance Risk Assessment process across the business lines on an ongoing basis and obtain business sign-off
  • Works closely with Financial Intelligence Unit and Business Financial Intelligence Units to manage Risk and Compliance matters in Canada
  • Execution of institutional surveillance reviews encompassing RC oversight, including, but not limited to, market conduct surveillance (such as insider trading, market manipulation, collusive activity, disclosure of confidential information), e-communication surveillance and other 2nd line of defence activities
  • Identification of Regulatory Compliance changes and potential impacts on GBM in Canada
Chicago, IL
Manager, Regulatory Compliance
Chicago, IL
Kerluke-Schoen
Chicago, IL
Manager, Regulatory Compliance
  • Provides recurring updates to management on current audit assignments and projects in process
  • Develop and foster constructive professional relationships with multiple disciplines and line management
  • Handling client issues relating to regulatory services including improvements, changes to the service, new business, operational issues and complaints
  • Establish trust and credibility with key stakeholders
  • Attract, develop and lead exceptional talent for audit compliance and business continuity
  • Work with senior leaders to develop compliance action plans
  • May coordinate program and product development with other compliance functions, including licensing
present
Chicago, IL
Senior Manager OTC Consumer Regulatory Compliance
Chicago, IL
Prohaska-Simonis
present
Chicago, IL
Senior Manager OTC Consumer Regulatory Compliance
present
  • This role may participate in the deployment of J&J Regulatory Compliance processes within the North America region, including but not limited to the closed-loop audit program, QScan, review of regulatory agency communications, significant inspection follow-up, and metrics collection and reporting
  • Assess compliance and quality risk management programs to assure they are implemented and maintained at the site
  • Provide proactive regulatory insight into new and upcoming regulations
  • Assist with the mitigation of compliance risk at the manufacturing site
  • Assure the execution of the JJRC common practices for independent Audit, Escalation (within JJRC), Recovery, Post Acquisition Assessment, Internal audit Oversight and Inspection Support & Readiness
  • Perform review of all Health Authority communication
  • Lead/Support site in preparing for Health Authority (HA) inspections (including Pre-Approval inspections), assist sites during HA inspections and with any resulting compliance commitments
Education Education
Bachelor’s Degree in Business
Bachelor’s Degree in Business
University of San Francisco
Bachelor’s Degree in Business
Skills Skills
  • Good client and prospect communications experience with excellent presentations skills and a high standard of written work
  • Strong planning and organizational skills
  • Establish strong collaborative relationships with cross functional team, including underwriting, finance, marketing and product development
  • Service contract, portable electronic insurance, and ancillary product and program development and implementation
  • Strong organizational and technical skills
  • Proven ability to maintain confidential communications
  • Strong written and oral communication skills
  • Have functional understanding of the company’s risk profile and the impact of product decisions on the company’s core financial performance
  • Knowledge of unit processes and operations
  • Flexible presentation skills and be personable, persuasive, cooperative and authorative
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15 Manager, Regulatory Compliance resume templates

1

Manager Regulatory Compliance CMB Resume Examples & Samples

  • This position manages the compliance function in assigned businesses to protect Company interests
  • This position also provides support on compliance matters that affect one or more of the HSBC businesses in Canada. Also assists in functional compliance management activities, including the fulfillment of compliance reporting requirements
  • Minimum of seven years proven and progressive financial services operations, compliance or legal experience or equivalent
  • Proven managerial, communications, analytical, organizational, project management and planning skills, including strong writing skills
  • Strong knowledge of pertinent regulations affecting assigned businesses
2

Manager Regulatory Compliance Rbwm Investment Funds Monitoring Resume Examples & Samples

  • Global Service Centres
  • Customer Service Centres
  • Complaints
  • IT / technology
3

Assistant VP Manager Regulatory Compliance Business Office Resume Examples & Samples

  • Bachelor’s degree in business management, finance, accounting, economics, mathematics, related fields or equivalent experience
  • Knowledge of the business and functional units supported, their products and services
  • Knowledge of project management principles, practices, techniques, and tools
4

Manager, Regulatory Compliance Resume Examples & Samples

  • Maintaining the Regulatory Enterprise Compliance Program (“ECP) for Canadian P&C (i.e. inventory of regulatory requirements, documentation of controls, assessments of control effectiveness, listing of deficiencies and related action plans, performing point in time 1st line of defense Monitoring & Testing (“M&T”) activities, etc
  • Providing subject matter expertise and coordination support to Canadian P&C’s participation in Enterprise level risk and compliance framework programs (i.e. Quarterly Regulatory Compliance Attestations, Operational Risk Loss Event reporting, etc.)
  • Environmental understanding (working)
  • Organizational understanding (working)
  • Change leadership (working)
  • Analytical Thinking (working)
  • Relationship Management (working)
  • Process co-ordination and Management (working)
  • Problem solving (working)
5

Reg W Assistant VP Manager Regulatory Compliance Resume Examples & Samples

  • Serves as the central point of contact for US Compliance and oversees the accuracy of the information regarding the regulation in the risk assessment tools while serving as the advocate for consistency of controls
  • Is knowledgeable about the results of any relevant BRCM reviews, CTAC testing and Internal Audits and provides input into the action plans to address any weaknesses identified. Provides support to ensure remediation efforts are on track for assigned regulation(s), regulatory requirements, and/or compliance risks
  • Assists senior management articulate any control weaknesses and status of plans to address these across HNAH. Initially, this information will be part of the Regulatory Controls Review RCR Controls Remediation Project for each regulation
6

Manager Regulatory Compliance Resume Examples & Samples

  • A managerial position of this scope will entail many relationships. A manager would have to work directly with compliance staff, business staff and varying levels of business management and will include regular contact with investment, trust and banking professionals as well as various departments within the business including, legal, operations and technology
  • Experience with Canadian Investment Adviser regulations or compliance would be an asset
  • Working knowledge of information technology tools required including: MS Excel, MS Word and portfolio management or investment industry software
  • Candidates with a recent legal degree (JD/LLB) are preferred
  • Ability to demonstrate effective use of judgment, interpretation, knowledge and skill in the application of regulations and compliance requirements
  • Strong writing skills for: 1) compliance reporting, 2) identifying, analyzing and escalating compliance issues, and 3) clearly communication regulatory obligations and expectations
7

AVP Manager Regulatory Compliance Resume Examples & Samples

  • Helps ensure business lines appropriately incorporate change to align with new or revised regulatory requirements. Supports business lines and LCOs in development of solutions to ensure compliance with assigned regulation(s), regulatory requirements and/or compliance risks
  • Helps ensure future business growth is attained in a responsible and conscientious fashion while the operation remains regulatory compliant and commercially sound
  • Minimum of four to six years proven and progressive financial services, compliance, and/or legal management experience, or equivalent
  • Broad scope of knowledge of assigned businesses, including products, operations, systems and organization and full understanding of all significant regulatory compliance requirements applicable to assigned business(es)
8

Manager Regulatory Compliance Hsbc Technology Services & Global Functions Resume Examples & Samples

  • The job holder will report to the Head of RC Global Functions & HTS and will have accountability and oversight of RC for either Global Functions or HTS
  • Minimum 3-5 years’ experience in Compliance, legal and/or the Global Functions or HTS businesses
  • Ability to maintain control, direction and motivation in an ever-changing environment
  • Strong relationship management skills with the ability to manage & engage multiple stakeholders, meet their expectations , negotiate in situations of conflicting interests and influence key decision makers in a positive manner
  • Strong communication and influencing skills – both verbal and written
  • Ability to understand and implement Group risk management policies
9

Manager Regulatory Compliance & Internal Control Resume Examples & Samples

  • Operation and on-going development of comprehensive regulatory management metrics that provide necessary reports to GWO Senior Management and GBM recipients for compliance and decision support purposes. The incumbent is responsible for ensuring that management and GBM Compliance is kept informed and that problems and issues are escalated appropriately
  • Effectively manage and supervise staff (through project assignments) by setting (or providing input for) performance expectations, monitoring performance, providing performance feedback as required
  • Work with Technology teams to design and transfer large-scale manual processes for automation by building business requirements and providing process expertise. Continue to acquire and enhance knowledge of GWO’s business strategies and policies, regulatory requirements, processes, and changing technology to effectively assist in the provision of business solutions and services to the end user business lines
  • Other ad-hoc projects for supporting operational and regulatory needs, as assigned
  • Ability to work with large quantities of data, to research and organize results
  • Ability to build relationships across different groups within the organization and cross-functional teams
  • Strong computer skills in MS Office and PC use
  • Ability to meet tight deadlines
  • Good oral and written communication skills and presentation skills
  • Process Improvement knowledge and solution implementation skills, including process mapping and analysis techniques
  • Practical knowledge / experience in GBM trading products and good understanding of standard operational processes is an asset
  • Knowledge of the Bank's business partners, products, technology and processes & policies is an asset
  • Supervisory/people management experience
10

Manager Regulatory Compliance E Testing & Control Resume Examples & Samples

  • Work collaboratively within the immediate team and more widely within the RC team
  • Contribute to your team’s delivery of outstanding performance (client service, behavioural expectations, and adherence to RC E-13 Testing & Control Plans)
  • Exercise any/all delegated authorities with due care and diligence
  • Think proactively and come up with ideas for enhancements to monitoring activity
  • Awareness of good risk management and governance frameworks including 3 lines of defence criteria
  • Good understanding and experience of Regulatory Compliance regulations
  • Understanding of the activities of relevant business lines and associated compliance risks
  • Ability to work under pressure and within tight time-lines and competing priorities
11

Manager Regulatory Compliance Resume Examples & Samples

  • The job holder will report to the Head of FCC & RC GBM and will have accountability for ongoing FCC and RC surveillance activities within GBM Canada Compliance. The Lead of GBM FCC and RC Surveillance will also have oversight over this role
  • Bachelor degree or equivalent experience
  • Industry related continuing education, including but not limited to CAMS and the Canadian Securities Course
  • Resourceful - ability to leverage resources available to achieve goals
12

Manager Regulatory Compliance Resume Examples & Samples

  • The job holder will report to the Head of RC GBM and will have accountability for ongoing RC surveillance activities within GBM Canada Regulatory Compliance. The Lead of GBM RC Surveillance will also have oversight over this role
  • Strong IT skills advantageous, especially in Excel
  • Knowledge of GBM businesses and products preferred, in particular Fixed Income products
13

Compliance Archiving & Regulatory Supervision Infrastructure Group Manager Resume Examples & Samples

  • Bachelors degree or relevant experience required
  • 10+ years of experience required
  • Experience with managing vendors
  • Experience in SLA management with strong Operational Background
  • Experience and solid knowledge and insight on the CA Orchestria, CA DLP, HP Autonomy, and EMC Info Archive products
  • Solid understanding of SMTP e-mail
  • Understanding of financial regulations and data privacy policies that govern over financial intuitions (such as Dodd-Frank, Sarbanes Oxley, SEC 17-4a, Swiss regulations, etc)
  • Database to infrastructure solutions
14

Manager, Regulatory Compliance Resume Examples & Samples

  • Manage the successful execution of a risk-based external client audits
  • Develop and foster constructive professional relationships with multiple disciplines and line management
  • Establish trust and credibility with key stakeholders
  • Attract, develop and lead exceptional talent for audit compliance and business continuity
  • Assess risks and formulate logical and supportable conclusions
  • Review and develop audit materials that meet all relevant professional practice requirements
  • Review and prepare concise, well-written audit communications, including final reports
  • Minimum 5 years professional experience with leadership responsibilities in audit, human resource, project management or related field
  • Ability to accurately gather, analyze and interpret data, define problems, and make. recommendations for resolution
  • Excellent Communication Skills, both written and oral
  • Quality and Execution Focused
15

Compliance & Regulatory Senior Manager Resume Examples & Samples

  • Planning and managing projects as required, meeting all deadlines in a timely manner
  • The interpretation and implementation of regulations
  • Provision of monitoring or internal audit services specific to compliance with regulatory requirements
  • On call advisory
  • Design and delivery of regulatory training tailored to meet client's needs etc
16

Learning & Talent Academy Lead Learning Relationship Manager To Regulatory & Financial Crime Compliance Resume Examples & Samples

  • Learning - Responsible for implementation of one or more Academies in Canada, using Group wide frameworks as a core product and adds to, tailors and changes to meet regional needs. Conduct needs analysis and demand planning for the Academy. Manage the ongoing Learning requirements of the business and plan the content to meet these requirements. Leverage Group vendor relationships and establish supplier options for regional activity. Act as final escalation point and subject matter expert for relevant Academy area
  • Minimum of eight years proven and progressive Human Resources (training) experience, or equivalent
  • Proven managerial skills
  • Strong analytical, organizational, problem-solving and communications skills
  • Strong knowledge of pertinent rules and regulations
  • Ability to exercise discretion and tactfully handle sensitive and confidential issues
17

Senior Audit Manager IA Compliance Regulatory Resume Examples & Samples

  • Leads coverage and maintenance processes that link audit entities, audits, and findings to laws and regulations in order to assess audit coverage of key regulatory compliance risks across the organization and enhance reporting of thematic general and institutional compliance control issues
  • Leads the effort to sustain and refresh relevant risk themes framework and taxonomy. This includes developing target operating models (TOMs) and delivering audit guides
  • Leads the review process of mapping risk themes to appropriate Internal Audit functions
  • Participates in the review and approval process of business monitoring quarterly summaries
  • Partners with Technology team to discuss assumptions and integration of technology to build the Risk Themes Framework
  • Maintains effective senior line management relationships and has a strong understanding of the businesses
  • Applies in-depth understanding of the inter-relationships of business and support units throughout the corporation and the relevant impacts to the overall control environment and audit approach
  • BA/BS or equivalent, preferably with a degree related to business, mathematics or statistics. Related certifications (CPA, ACA, CFA, CIA, CISA or similar) are a plus, and CAMS certification is a strong plus
  • 7+ years experience in a related role with experience in business, functional and people management, with proven abilities in taking responsibility for executing concurrently on a portfolio of high quality deliverables to stakeholders according to strict timetables
  • Leads application of in-depth level of expertise in one or more of the corporation's businesses and leverages this knowledge into a leadership role in one or more teams
  • Leads by demonstrating strong judgment, political astuteness, and sensitivity to cultural diversity
18

Audit Manager, Compliance Regulatory Resume Examples & Samples

  • Supports coverage and maintenance processes that link audit entities, audits, and findings to laws and regulations in order to assess audit coverage of key regulatory compliance risks across the organization and enhance reporting of thematic general and institutional compliance control issues
  • Supports the effort to sustain and refresh relevant risk themes framework and taxonomy, from developing target operating models (TOMs) to delivering audit guides
  • Supports the review process of mapping risk themes to appropriate Internal Audit functions
  • Partners with Internal Audit functions and Compliance (second line of defense) to align risk taxonomies and assign audit hours against applicable risk themes and ensure adequate coverage
  • Supports the review and approval process of business monitoring quarterly summaries
  • Uses excellent project management and interpersonal skills in order to influence a wide range of internal audiences including respective product, function, or regional executive management partners
  • Partners with Directors and Managing Directors to develop approaches for addressing broader corporate emerging issues
  • Comprehensive understanding of different Internal Audit standards, policies and local regulations; applies a broad and comprehensive knowledge of high risk areas including: consumer banking, technology management; program management; regulatory compliance and supplier management
  • Relevant knowledge in working with compliance programs that have been established to comply with the local and U.S. regulatory requirements, second line of defense policies and procedures, provisions and guidelines established by the federal regulators and all applicable regulations governing banking activities and operations
  • 6+ years experience in a related role with experience in business, functional and people management, with proven abilities in taking responsibility for executing concurrently on a portfolio of high quality deliverables to stakeholders according to strict timetables
  • Proficiency with PowerPoint, Excel, and Word is essential. Familiarity with SharePoint is a strong plus
  • Demonstrates strong judgment, political astuteness, and sensitivity to cultural diversity
19

Associate Manager Regulatory Compliance Resume Examples & Samples

  • Project management & organizational skills
  • Strong communication skills, ability to provide clear and engaging messages
  • Broad regulatory experience, with an emphasis on the management of safety information, labelling management and change control
  • Clear judgment , ability to make decisions
  • Accuracy, attention to detail & ability to manage complexity and act with speed
  • Good time management , results-driven & a can-do attitude
  • Built strong partnership with regional , cluster and local stakeholders and in particular with the equivalent CCDS regional Medical Affairs colleague
  • Write or update key guidance documents for EMEA for the management of CCDS applications/reviews for regional and local roles. Communicate and familiarize/ train the stakeholders with the guidance docs
  • Maintain good cooperation and timely and regular alignment with the Global CCDS team and EMEA regulatory management for all aspects of CCDS updates and submissions to the relevant Authorities
  • Work closely with regional Medical Affairs colleagues to facilitate the creation of local or regional Clinical overviews enabling the safety submissions
  • Liaise with local or regional regulatory colleagues to support the CCDS driven safety submissions
  • Coordination and Project management of major safety changes such as PRAC labelling recommendations etc. and HA commitments
  • To be trained in and remain compliant with appropriate Company Standard Operating Procedures
  • In cooperation with regional Medical Affairs deliver training and encourage a culture of compliance across EMEA in relation to the optimal CCDS management
  • 5 years Post Graduate or more with experience in the OTC or pharmaceutical industry working in Regulatory Affairs
  • Experience in safety variations is valued. Previous experience in working with CCDS development, maintenance or implementation would be advantageous
  • Strong written and verbal communication skills & attention to detail are crucial
  • Proven ability to work effectively in a matrix environment on cross-functional teams and to facilitate decision making in collaboration with others
  • Experience in project Management would be advantageous as well as experience in managing complexity and interacting with multiple markets
20

Manager, Regulatory Compliance for Wrigley Resume Examples & Samples

  • Participates in cross-functional and cross segment project teams to provide strategic Scientific and Regulatory Affairs advice, anticipates regulatory issues and works with legal counsel, consultants, suppliers, and trade associations and external partners to clarify and resolve these issues
  • Provides leadership for compliance activities in assigned markets to ensure adherence to internal compliance processes and practices, and continuously reviews and improves these processes and procedures
  • Has responsibility for assuring ingredients, formulas, labelling, and packaging are in full compliance with laws and regulations in countries where they are sold
  • Has responsibility for assuring claims are in full compliance with laws and regulations in the countries they are made
  • Proactively monitors regulatory activities in assigned markets; works internally (including with cross-segment Mars partners) and externally to address and influence proposed regulations to preserve Wrigley’s freedom to operate
  • Develops SRA positions regarding the safety and acceptability of products and ingredients, and leads activities to ensure both the continued use of ingredients and gain approval for new ingredients in assigned markets
  • Prepares and submits documentation to regulatory agencies and other external bodies required to substantiate and approve claims
  • Represents the company externally in trade and scientific organizations to address industry issues and ensure company positions are communicated
  • Leads complex and strategically important SRA projects, some with global scope and impact
  • Mentors and may supervise the day-to-day activities of junior level associates on team
  • Performs other regulatory related assignments as needed
21

Manager, Regulatory Compliance Resume Examples & Samples

  • A minimum of a High School diploma is required. Bachelor’s degree or equivalent preferred
  • A minimum of 8 years of related experience and/or training, or equivalent combination of education and experience, is required
  • Experience working in a regulated GMP environment is required
  • Prior experience and knowledge of controlled substance regulations is preferred
  • Previous experience communicating across all levels of an organization is preferred
  • Previous auditing experience is required
  • Familiarity with Quality System Regulations is required
  • Previous experience managing investigations is required
  • Previous experience resolving CAPAs required
  • Previous exposure to DEA audits is preferred
  • Previous experience with notified body audits is strongly preferred
  • This position is located in Vacaville, CA and may require minimal travel.Compliance
22

Manager, Regulatory Compliance Resume Examples & Samples

  • Being the outsourcing team’s regulation expert for all post execution trade regulations
  • Working with the account managers in the team, their clients and prospective clients including in sales presentations and during implementation) to explain the impact of regulations on them and the practical solutions that SS&C offers or will need to build to achieve those
  • Ensuring the exiting services to clients that meet regulatory requirements, are robust and are achieved each day e.g. daily EMIR reporting to trade repositories; this will include taking the lead where issues arise
  • Advising on and devising servicing solutions to meet regulatory changes on existing regulations processes e.g. on confirmation timings, portfolio reconciliation, reporting to trade repositoriesfor EMIR etc
  • Keeping an eye on the development of future regulation changes such as MIFID II and proposed SFT regulation and for communicating that to the team and clients and making preparations in advance to ensure we have the solutions in place to enable our clients to comply in time
  • Providing expertise to the team, existing clients and prospects in regulatory matters and reporting requirements for a variety of trades including equities, bonds, FX, repo, exchange traded and OTC derivatives
  • Ensuring all lifecycle management processes are compliant with all applicable regulation e.g.including MIFID II and EMIR etc
  • Anticipating the future regulatory needs for servicing post execution lifecycle events and report for our clients. Creation of new solutions for requested services or changes to services using the technology and the resources available
  • Attend relevant industry events
  • Reducing process risk for the processing team in India for regulatory solutions and guiding them toward controlled, robust procedures on the activities done for the clients
  • Handling client issues relating to regulatory services including improvements, changes to the service, new business, operational issues and complaints
  • Contributing to senior strategic and service reviews with clients as necessary
  • Overall responsibility for the performance of regulatory reporting services
  • Responsibility for the implementation of new clients on to the regulatory platform, the set up of servicing teams and the smooth running of day to day regulatory servicing
  • Working with technology and other servicing groups on projects to change or devise solutions for regulation needs
  • Regulation of trading and post execution processing / reporting requirements: MIFID I and II, EMIR, IOSCO BCBS, SFTR etc
  • Post execution middle office lifecycle management of traded instruments and OTC Derivatives
  • Responsibility for the integrity of regulation based processes and the daily regulatory reporting for all the teams’ clients
  • Project involvement with IT developers and operations experts
  • Good client and prospect communications experience with excellent presentations skills and a high standard of written work
  • Dealing with operations units in separate locations
  • Education the team on existing regulations and future proposals
  • Due to global nature of our clients the candidate will need to have an understanding of equivalent regulation abroad e.g. Dodd Frank or requirements in Australia
  • Experience of working effectively directly with clients, with expert client account managers and with remote operations teams
  • Flexible presentation skills and be personable, persuasive, cooperative and authorative
  • Post graduate Degree
23

Program Manager, Regulatory Compliance Resume Examples & Samples

  • Participates in site and/or regional PD Regulatory Disclosures departmental meetings
  • As needed, advises as an ad hoc member in Regulatory Affairs Functional Teams (RAFT) for assigned product development projects. Represents Regulatory Disclosures and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
  • As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects
24

Senior Audit Manager, Regulatory Compliance Resume Examples & Samples

  • Minimum of ten years proven and progressive audit, business, and/or accounting experience or equivalent; substantial experience performing AML audit required
  • Minimum of a bachelor’s degree in business, accounting, finance, related field or equivalent experience
  • Strong managerial skills, written and verbal communication skills, analytical, problem-solving, organizational, lateral thinking and interpersonal skills
  • Broad knowledge of the Company, Group and financial services industry, business supported and the regulatory framework they operate in
  • In-depth understanding of the business, risks and related controls within areas of responsibility
  • Ability to apply technology or expertise to business issues or operational problems
  • Professional certification (s) preferred
25

Regulatory & Product Compliance Manager Resume Examples & Samples

  • 3-5 years of experience with import/export consumer product safety compliance program management
  • Strong experience with Canadian Consumer Product regulations preferred, CCPSA. US and Mexico also apply: CPSIA, Profeco, IEFTL
  • A mix of compliance, team leadership and project management experience
  • Preferred qualifications
  • Common sense, great judgment, and a good sense of humor
26

Manager Regulatory Compliance Rbwm Hifc Monitoring Resume Examples & Samples

  • Minimum of 5-7 years proven audit, compliance, financial services operations and/or regulatory experience, or equivalent
  • Mutual funds and Branch Managers Course (IFIC, ICB or CSI). CFP or financial planning knowledge is considered an asset
  • Proficiency with personal computers and pertinent mainframe systems, software packages, Word and Excel
27

Manager, Regulatory Compliance Resume Examples & Samples

  • Interpret and apply regulations to existing Hologic products to ensure compliance with these regulations in all OUS sites, dealers and distributors
  • Define, execute, monitor, collate, and publish audit schedules in coordination with divisional and corporate quality compliance teams
  • Participate in global quality compliance teams and support implementation of harmonized procedures
  • Ensure adherence to the company quality audit schedule in international sites
  • Manage international employees’ compliance with current corporate training requirements
  • Provide monthly reporting to regional and international management on the status of internal and external audits, open actions, overdue activities and future audits
  • Interface with Hologic employees, dealers and distributors regarding quality compliance activities
  • Interact with regulatory agencies in regards to audits and responses until closure
  • Provide training to international employees on audit management
  • Advise and guide management and other personnel in other departments on the interpretation and application of regulations impacting compliance activities
  • Maintain current knowledge of current and proposed regulations, laws, guidelines standards, and initiatives. Assess impact and disseminate throughout the organization for continued regulatory and quality compliance
  • Develop staff skills, abilities, and experiences for succession
  • Bachelor or equivalent in biological sciences, life sciences or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 7 years’ experience in the in vitro diagnostics, medical device or pharmaceutical industries; with at least 4 of those years in a wide breath of compliance roles
  • Must have certification as an ISO Lead Auditor
  • Must have experience interfacing with competent authorities regarding audit activities and resolution of observations
  • Must have advanced knowledge of applicable regulations and standards related to medical devices internationally (ISO 13485, Medical Device Regulation, Anvisa, CFDA, etc.)
  • Comfortable leading in a high pressure environment typical of regulatory audits
  • Ability to independently plan, execute, and/or problem solve moderate to complex situations
  • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Must demonstrate initiative, balanced assertiveness working as a team player
  • Solid oral and written communication skills with ability to communicate effectively and professionally with medical personnel
  • Regularly required to sit
  • Regularly required to use a computer keyboard, mouse, and monitor
  • Regularly required to talk and hear
  • Occasionally required to walk to meeting locations
  • Required to use close vision and adjust focus
  • Work is performed primarily in an office environment
  • Travel expected not to exceed 5%
28

AVP Manager Regulatory Compliance Assurance Resume Examples & Samples

  • Supports the development and implementation of a schedule of reviews of all U.S. Compliance functions, in accordance with the Compliance FIM, Sections B2.1.3, and CRMP Manual. Assists and works alongside other members of the team and makes decisions based on knowledge and experience. When unsure, guidance should be sought from Immediate Supervisor or specifically assigned Review Lead on assignment. Interacts effectively with all levels of Compliance teams and the businesses they support as warranted. Acts as part of a team which will conduct assurance reviews on all second line of defense compliance functions within the U.S. Has the ability to learn and work effectively in a dynamic and changing environment. Acts proactively and develops and suggests ideas for enhancements to the team's activities
  • No supervisory responsibilities
  • No P&L responsibilities
  • Minimum five to seven years proven and progressive compliance and/or audit experience, preferably in the financial services sector; experience in both audit and compliance is a plus
  • Proven ability to learn and understand new areas and concepts in a short period of time
  • Ability to perform job responsibilities in a newly formed department
29

Senior VP-real Estate Regulatory & Legal Compliance Manager Resume Examples & Samples

  • Takes ownership of work streams for the annual preparation of the bank’s recovery and resolution plans related to its occupied locations
  • Familiarity (or exhibit the ability to quickly develop an in-depth familiarity) with Citi’s businesses, operations, legal entities, global real estate portfolio and continuity of business plans
  • Ability to interpret and translate information from multiple parties into detailed, comprehensive project plans
  • Ability to consider multiple approaches, reconcile competing corporate interests and prioritize objectives
  • Ability to interpret data, analyze financial, operational and legal input
  • Ability to drive project objectives
  • Strategic and analytical thinker
  • Strong problem solving ability
  • Strong oral and written communications skills; proficiency drafting and understanding complex documents preferred
  • Keen program management skills and collaborative leadership abilities
  • A high comfort level with working in a fast paced, unstructured, unpredictable and frequently changing environment
30

Regulatory Compliance Implementation Project Manager Resume Examples & Samples

  • Develop detailed project plans and monitor and track progress
  • Manage changes to project scope, schedule and costs
  • Assist in the definition of project scope and objectives, involving all relevant stakeholders
  • Assist in design, build and reporting of appropriate KPIs on project effectiveness
  • Create and maintain comprehensive project documentation
  • Coordinate internal resources and third parties/vendors for project execution
  • Report and escalate to management as needed
  • Proven work experience in project management in an investment bank or other financial institution. Focus on regulatory implementation projects preferred
31

Product Manager Regulatory Compliance Analytics Resume Examples & Samples

  • At least 7 years’ experience in banking
  • At least 3 years’ experience in compliance, internal audit, GRC or risk
  • At least 3 years’ experience as a business analyst / writing business requirements
  • Ability to take a high-level concept, solidify it and communicate it to a non-subject-matter-expert team
  • Interest in software development on the cloud
  • Readiness to travel 15% travel annually
  • At least 10 years’ experience in compliance, internal audit, GRC or risk
  • Experience working with software development teams to create new software products
  • Exposure to agile development processes
  • Exposure to cognitive computing
  • Master's Degree / PMP (Project Management Professional)
32

Distribution Strategy Compliance & Regulatory Oversight Group Manager Resume Examples & Samples

  • Manage and provide leadership of ADA compliance oversight and OCC approval process for CBNA Distribution Strategy function in North America
  • Drive strategic agenda and collaborate with key business partners in CRS, CRA, ATM strategy, Fair Lending and Community Development, and other control teams to insure proper oversight of retail real estate related legal /compliance matters and improve controls
  • Work closely with internal and external legal teams to timely address ADA compliance issues in branch portfolio, review customer and staff concerns, and insure that customer complaints are responded to appropriately
  • Oversee life cycle of issue management and resolution closure team
  • Establish and oversee budget planning for remediation measures
  • Oversee team that monitors and self identifies issues and raise CAPS as required, and oversee MCA reporting and monitoring of issue management status
  • Stay abreast of compliance and regulatory requirements. Synthesize and disseminate to leadership team as appropriate
  • Drive oversight of issue management and resolution and work with partners in establishing corrective action plans, implementation and completion
  • Identify optimal strategic solutions for ADA compliance issues to meet Citi's requirements, satisfy appropriate regulations, and insure functional branch operations
  • Institute regular reviews to track and monitor issues and progress
  • 15+ years of experience in financial services industry
  • Bachelor’s degree required; Legal background preferred, Juris Doctor degree a plus
  • Good judgment and ability to identify issues and prioritize
  • Must have understanding of business objectives
  • Effective team leader with strong negotiation and communication skills
  • Ability to navigate across matrix organization and drive results through influencing of internal and external partners
33

Manager, Regulatory Compliance Resume Examples & Samples

  • Functional responsibilities include internal audits, 3rd party inspection readiness and management, and Quality System compliance training programs
  • Lead and participate on cross-functional and global teams representing key stakeholders in developing and managing policies, standards, and procedures. This includes developing procedures and practices that can be deployed globally
  • Partner with JJVC sites and related organizational units to ensure that regulatory compliance procedures are compliant, effective, and efficient. Utilize stakeholder input to ensure that the overall enterprise objectives are achieved
  • Represent JJVC on JJRC teams and working groups. Provide input into segment initiatives. Interpret and integrate resulting segment policies and standards into JJVC global operations
  • Manage FDA and other governmental or ISO Notified Body inspections conducted at JJVC locations, including pre- and post-inspection support, as requested. Serve as company representative during regulatory inspections. Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary
  • Manage associated assessment and remediation activities as a result of internal and external assessments. Align and deploy JJVC Quality System procedures (worldwide) in accordance with segment and enterprise standards
  • Consult with management, manufacturing, R&D, and laboratory staff to help formulate and implement proactive regulatory compliance strategies and controls
  • Maintain a leadership presence with government regulators and external professional organizations in order to monitor and influence regulatory issues. Interpret and integrate regulatory changes (FDA/ISO/ ANVISA/JPAL/CMDCAS, etc.) into franchise procedures
  • Develop and maintain key quality and regulatory compliance performance metrics. Participate in developing and presenting departmental materials for Management Review
  • Actively participate in continuous improvement efforts for global continuous improvement activities
  • Supervises staff responsible for the preparation and presentation of regulatory compliance training materials for regulatory, quality, technical, and managerial personnel
  • Promote a culture of compliance to regulations, standards, and procedures and risk management throughout the organization. Support departmental objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures. Direct, supervise and train staff of Compliance Specialists/Auditors
  • Manage and lead assessments, analyses, alignment, and implementation activities for regulatory compliance procedures across the organization and provide directional input into segment and enterprise standards
  • Direct, supervise and train staff. Develop and monitor development and training plans
  • Assist project teams with identification of quality system requirements to ensure compliance with regulations
  • Acts as liaison with external auditors during third party/regulatory audits
  • Monitor regulatory agencies for changes in requirements and evaluate impact to the organization
  • A minimum of a Bachelor's degree is required; a degree in a technical field is preferred; an advanced degree is an asset
  • A minimum of 8+ years of business experience is required
  • A minimum of 4+ years of working experience in the quality assurance / compliance audit environment is also required
  • Proven track record of successfully leading and/or facilitating FDA inspections, both front room and back room is required
  • The ability to effectively manage people (both directly and indirectly) is an asset
  • Experience managing projects that include cross-functional teams representing diversified areas is preferred
  • Strong communication, organizational, negotiation and interpersonal skills is required
  • A certification in RAC, ASQ - CQA, CQE or SCQE, and/or ISO Lead Assessor is an asset
  • Understanding and knowledge of a broad set of regulations and standards (21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, etc.) is required
  • This position may require up to 15% domestic and international travel and will be based in Jacksonville, Florida
34

SVP Regulatory Compliance Senior Manager CMB Resume Examples & Samples

  • Ownership of the “Banking” regs aligned to CMB (Core Lending and Deposits, distinct from Securities regs impacting CMB)
  • Coverage of all related CDSAs - ensuring timely completion, accuracy and meeting of “minimum standards”
  • Support for completion of aligned PRAs (Product Risk Assessments), ensuring timely completion and connection to business activities
  • Input to and accountability for relevant sections of the ERA, using CDSA data and highlighting business, industry and market trends
  • Primary advisory support to LOB operational, 1LOD functions and other risk stewards, including
  • Marketing reviews
  • Cross Border activity
  • Product reviews (CMB, non-referral products)
  • Third Party Risk Management
  • The number of direct reports varies from 0-15, depending on the area supported
  • Some P&L responsibilities, as distributed
35

Manager, Regulatory Compliance Resume Examples & Samples

  • 5+ years of finance/banking experience with risk experience, preferably at a managerial level
  • 3+ years of managerial experience, which includes placement, work direction, coaching, and performance management
  • Deep understanding of regulatory principles and relationships in the financial services industry
  • Understanding of credit management
  • Knowledge of unit processes and operations
  • Experience effectively interacting with regulatory bodies (i.e. Federal Reserve, OCC, etc.)
  • Effective writing skills, including grammatical usage, persuasive copy and style
  • Strong planning and organizational skills
36

Regulatory Compliance Risk Manager Resume Examples & Samples

  • Defines Allstate Financial’s (AF) Regulatory Compliance Risk and Return Management objectives and assists in the development of the risk management strategy
  • Drives overall risk return management efforts across AF by leveraging credibility as an expert in regulatory compliance risk management knowledge and through strong relationships to collaborate with operational and insurance risk leadership
  • Performs operational risk assessments and influences proper managing, monitoring, reporting, and escalation structure to optimize risk and return
  • Provides extensive expertise and project/process management to AF programs
  • Designs and implements improvements to current AF Programs to ensure compliance systems/processes are optimal
  • Researches, interprets, and analyzes trends and sources of risk across AF portfolio and leverages information to advance risk / return decision making
  • Implements reporting, monitoring, and escalation procedures to ensure that AF is operating within its defined risk appetite
  • Provides thought leadership in managing various programs, including establishing priorities and key measurements to inform on emerging risks
  • Lead various cross – functional teams to optimize program managements in pursuit of managing within risk/return principles and tolerances
  • Interacts with senior management and ability to present complex matters
  • 7+ years of experience; Bachelor’s Degree Required
  • Life insurance knowledge strongly preferred
  • Advanced knowledge of professional and regulatory standards
  • Exceptional customer service and drive innovation to create an atmosphere supports new ideas, efficiency and initiative
  • Innovative thinking to identify and influence process improvements
  • Strong communication and collaboration skills
  • Ability to and desire to move from project to project quickly learning while adding value to the project team and the business
  • Develop and/or revise tactics to support changing business strategies and direction
  • Decision making capabilities including problem solving approaches, decision frameworks; ability to design and lead complex analysis
  • Structure documents to effectively communicate with senior management and drive leadership alignment
  • Excellent presentation skills; dynamically (persuasively) presenting ideas to management
  • Advanced ability to manage multiple priorities given aggressive timelines; comfortable performing in a fast paced, dynamic and ambiguous business environment
  • Experience with leading employees and developing staff
37

Internal Audit Manager, Regulatory Compliance Resume Examples & Samples

  • Minimum of 6 years related audit and/or compliance experience
  • Working technical knowledge of major Consumer protection laws and regulations such as TILA/Regulation Z, Consumer M/ Leasing, ECOA/Regulation B, FCRA, FACTA, FDCPA, SCRA, BSA/AML, OFAC, EFTA, UDAAP, and GLBA
  • Demonstrated strong project management skills and organizing ability with successful experience in concurrently managing multiple projects at varying levels of technical difficulty
  • Knowledge of business and IT processes and how they intersect with compliance risks
  • Knowledge of US GAAP, SEC reporting requirements, COSO, Standard No. 5, custom attestation and agreed upon procedure engagements, IIA standards and audit processes and procedures, a plus
  • Public accounting and/or start-up experience, a plus
  • Oracle, ACL, and SQL knowledge, a plus
  • Technology and/or vehicle leasing specific industry experience, a plus
38

Manager, Regulatory Compliance Resume Examples & Samples

  • Accessing legacy accounting systems
  • Assisting in the preparation of cumulative allowable cost worksheets and providing support documents as requested by the auditors
  • Preparing incurred cost submissions, cost accounting standards disclosure statements, indirect rate analysis and drafting responses to government audit reports
  • Provide financial analysis and support in an audit liaison role with the government contract auditors
  • Minimum of 5-10 years of relevant work experience
  • Bachelor’s degree in Accounting, Business Admin or related field is required
  • Fundamental knowledge of Cost Accounting Standards (CAS), Generally Accepted Accounting Principles (GAAP) and the Federal Acquisition Regulation (FAR)
  • Good communications skills , including the ability to maintain an effective and professional working relationship with government representatives
  • Strong computer skills including MS Excel, MS Access, MS Word and Cognos
  • Working knowledge of Deltek CostPoint or similar accounting platform
39

Manager, Regulatory Compliance Resume Examples & Samples

  • Provide primary analysis of proposed rulemakings that are likely to have a significant impact on the company’s business units and develop recommendations for appropriate compliance strategies
  • Coordinate corporate, group, and divisional regulatory compliance efforts in the hazard management arena
  • Audit the company’s hazard management and loss prevention programs through continual review of policies, procedures, rules and guidelines; determine potential for environmental liability issues
  • Facilitate the development of appropriate compliance plans and make recommendations to improve overall program effectiveness using annual loss prevention plans, risk surveys, reports/audits developed by outside agencies, and other available sources of information
  • Assist with the implementation of programs and procedures that assure compliance with DOT regulations at affected facilities; supervise the day-to-day activities of the DOT Compliance Administrator
  • Maintain the company’s Process Safety Management and Risk Management Programs. Ensure all regulatory requirements have been satisfied and necessary actions have been taken at all applicable facilities to maintain compliance
  • Coordinate the Process Hazard Analysis function and the Management of Change program; ensure proper execution by all applicable parties
  • Ensure ongoing compliance with hazardous waste management matters at all affected facilities. Coordinate all disposal activities and recordkeeping and reporting requirements
  • Coordinate the completion and filing of all required regulatory reports, including annual chemical inventories (Tier II), toxic releases (Form R), pesticide repackaging, and USTs, among others
  • Maintain certifications and other records necessary to demonstrate on-going compliance with federal, state, and local health, safety, and environmental protection rules and regulations
  • Serve as a resource to management, supervision, and the workforce in order to assist them in effectively performing their regulatory compliance and other hazard management tasks
40

Associate Manager, Regulatory Compliance Resume Examples & Samples

  • Write or update key guidance documents for management of CCDS applications/reviews for regional and local roles. Communicate and familiarize the stakeholders with the guidance docs
  • Maintain timely and regular alignment with the Global CCDS team and the served regulatory management for all aspects of CCDS updates and submissions to the relevant Authorities
  • Liaise with Medical Affairs colleagues to support the creation of local or regional Clinical overviews supporting the safety submissions, where relevant
  • Liaise with local, regional & global regulatory colleagues to support the CCDS driven safety submissions
  • Regional monitoring & tracking of CCDS/safety submissions
  • Regional Coordination and Project management of major safety changes and Health Authority commitments
  • To be trained in and remain compliant with appropriate Company Operating Procedures
  • To deliver training across APAC in relation to the optimal CCDS management
  • Other regulatory affairs compliance job-scope as required to drive & support the protection & growth of JNJ consumer business
41

Manager, Regulatory Compliance Resume Examples & Samples

  • Possess working knowledge of Cost Accounting Standards (CAS), Generally Accepted Accounting Principles (GAAP) and the Federal Acquisition Regulation (FAR) cost principles as they apply to practices and procedures
  • Provides recurring updates to management on current audit assignments and projects in process
  • Assists in the investigation and resolution of compliance problems, questions or complaints received from government regulatory agencies
  • Assist in the preparation of the annual incurred cost audit submission and subsequent audit support of previously prepared submissions
  • Prepare draft contractor responses to contract audit reports and other regulatory compliance related matters
  • Prepare draft policies and procedures, or revisions to existing documents
  • Possess the ability to use a variety of electronic business and software tools to obtain, organize, and present relevant business data for management
  • Participate in the compliance training program as an instructor /content manager
  • Participate in meetings with Defense Contract Management Agency (DCMA), and Defense Contract Audit Agency (DCAA) representatives
  • Five (5) to ten (10) years of relevant experience with government contract accounting experience
  • Knowledge of Federal Acquisition Regulation (FAR), including the allowability, allocability and reasonableness of costs
  • Working knowledge of Deltek CostPoint
  • Possess the ability to work with the various internal functional groups including accounting, legal, human resources, contracts, pricing, accounts payable and internal audit
  • Strong understanding of the Cost Accounting Standards (CAS) and areas subject to audit by DCAA at a major contractor location
  • A Certified Public Accountant and/or advanced degree is desirable
42

Enterprise Global Regulatory Compliance Delivery Manager Resume Examples & Samples

  • Ability to work in a fast pace environment
  • Ability to distill complex issues into meaningful directive communications
  • Experience planning and managing projects/programs that are resourced and executed by geographically-dispersed teams
  • Experience leading technology infrastructure projects
  • Experience working with software and security development lifecycles
  • Demonstrated excellence in communicating and presenting complex information to technical and non-technical stakeholders, both verbally and in written form
  • Understanding of project/program financials (e.g., budgeting, assessing financial impact, working with financial analysts)
  • Knowledgeable of at least one software development methodology (e.g., Agile, Scrum, SDLC, Waterfall)
  • Knowledgeable of Microsoft platform technologies and tools
  • Clear and concise oral and written communication
  • Proven skills in stakeholder expectations management
  • Results oriented; self-directed ability to drive change in unstructured environment
  • Business and financial acumen
  • Customer-oriented attitude, with great presentation and interpersonal skills
  • Knowledgeable of enterprise global regulatory compliance requirements, technologies and tools
  • Experience with RSA Archer or other eGRC platforms and technologies
  • Experience with security incident management
  • Experience with vulnerability management technologies (e.g., Qualys, Rapid7)
  • Experience in several of the following areas: infrastructure solutions (especially Microsoft); hardware/software installation, virtualization, configuration; web server support; cloud technologies; networking; data center operations; platform migration; enterprise directories; Exchange; IIS; Windows Server; SQL Server; SharePoint
  • Experience with operation management, systems security, testing, data storage, (remove – databases), application development, machine learning and mobility considerations
  • Experience with security practices for cloud (PaaS and SaaS) environments
43

Senior Manager, IT Regulatory Compliance Resume Examples & Samples

  • A minimum of a Bachelor's Degree in Science required with a focused degreed in IT, Engineering, Business, and Quality & Regulatory Compliance related discipline is preferred
  • A minimum 7 years of progressive experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment is required
  • Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems is required
  • Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements is required
  • Experience effectively interfacing with global regulatory agencies, e.g., FDA, MHRA, TGA, notified bodies, etc. is required
  • Experience interpreting regulations and translating regulatory requirements into practical strategies is required
  • Ability to influence, negotiate, and build credibility is required
  • Ability to resolve complex regulatory compliance issues is required
  • This position will be based in Raritan, NJ and requires up to 20% domestic and international travel.Compliance
44

Senior Manager OTC Consumer Regulatory Compliance Resume Examples & Samples

  • Proactively identify, prioritize, and communicate compliance risks at assigned site
  • Assess compliance and quality risk management programs to assure they are implemented and maintained at the site
  • Collect and review data to identify compliance signals that warrant attention
  • Communicate/Notify site, and where appropriate segment/enterprise, leadership of compliance risks
  • Assist with the mitigation of compliance risk at the manufacturing site
  • Assure the execution of the JJRC common practices for independent Audit, Escalation (within JJRC), Recovery, Post Acquisition Assessment, Internal audit Oversight and Inspection Support & Readiness
  • Ensure timely follow-up of ERC assessments CAPA plans. Work with organizations in region to achieve green/green status against approved CAPA plans
  • Provide Compliance oversight to strategic projects/initiatives
  • Engage in product lifecycle management process and key supply chain improvement projects (e.g. key new product launch, significant changes, etc.)
  • Engage with McNeil global process owners on key quality system process changes
  • Lead/Support site in preparing for Health Authority (HA) inspections (including Pre-Approval inspections), assist sites during HA inspections and with any resulting compliance commitments
  • Monitor issue resolution progress and identify emerging shortfalls and risks for management notification
  • Perform periodic review of quality records, such as investigations, CAPAs, and complaints
  • Provide compliance advice to Sites for critical issues and problem resolution
  • Actively participate in site escalations and support crisis management
  • Review investigations with high regulatory potential, including those associated with FARs & recalls
  • Perform review of all Health Authority communication
  • Support applicability assessments of cGMP and other Health Authority regulations to site
  • Consult with site leaders for the escalation and resolution of Quality and Compliance issues
  • Ensure alignment of US OTC policies and standards for the strategic alignment with of J&J and Consumer segment policies and standards
  • Provide proactive regulatory insight into new and upcoming regulations
  • Participate in the Siten project/management review forums (e.g., Quality Councils) to uphold effective risk identification and management, quality system evaluation, and appropriate response to issues
  • Partner with Compliance peers across sites, Consumer segment and Enterprise regulatory functions for strategic consistency and leveraging opportunities
  • Maintain personal professional development on new/upcoming requirements and technologies
  • This role may participate in the deployment of J&J Regulatory Compliance processes within the North America region, including but not limited to the closed-loop audit program, QScan, review of regulatory agency communications, significant inspection follow-up, and metrics collection and reporting
  • Working conditions require resolution of complex problems within tight timelines
  • A minimum of a Bachelor’s degree is required. An advanced degree is preferred. A focused degree in science, engineering, or equivalent is strongly preferred
  • Minimum of eight (8) years of experience in a quality and/or compliance environment within a highly regulated industry is required
  • Understanding of requirements for compliant drug and medical device manufacture including facilities, equipment, documentation, testing, and product flow is required
  • Strong knowledge of quality and compliance in a regulated manufacturing environment (GMP) is required
  • Experience with or how regulatory bodies approach inspections and how to respond to regulatory body observations is required
  • Knowledge of regulatory and development process (both pre-approval and post-launch monitoring) and scale-up is preferred
  • Working knowledge of New Drug Regulations and GxP/Quality System Regulations is preferred
  • Working experience in a Consent Decree environment is preferred
  • Experience working with statistics, analytics and data trending is preferred
  • Experience managing multiple, highly complex projects is preferred
  • Previous experience working inside a regulatory agency (i.e. FDA, MHRA) is preferred
  • Proficient with MS Office products (Word, Excel, PowerPoint, Outlook, Visio) and visual aid software is required
  • May require up to 30% local and global travel, with higher peaks depending on business needs.Compliance
45

Manager, Regulatory Compliance Resume Examples & Samples

  • Lead a team in the divisional regulatory compliance process focused on Medical Device Reporting and Medical Device Vigilance Reporting. Ensure overall compliance with applicable global regulatory and statutory requirements regarding MDRs/MDVs. Manage product containment oversight for multiple manufacturing locations in the division
  • Correspond with the FDA and global health authorities regarding regulatory reporting issues. Oversee correspondence with USA and global regulatory bodies
  • Manage the divisional regulatory reporting process for MDRs/MDVs to ensure overall compliance with applicable regulatory and statutory requirements
  • Contract and manage group of medical professionals for assessment of harm severity
  • Oversee communications with global health authorities regarding adverse events, , and other queries regarding compliance
  • Manage work team performance, including individual performance coaching and delivery of period performance feedback/reviews
  • Maintain expert knowledge of applicable Federal and foreign regulations pertaining to MDRs/MDVs, and complaint handling
  • Continue to assess and align the divisional processes with corporate policy, guidance, and procedures
46

Manager Regulatory Compliance Resume Examples & Samples

  • Assist with the development of a hospital-wide regulatory compliance program specific to healthcare
  • Facilitates implementation of federal, state and local requirements, including Joint Commission requirements, related to patient safety
  • Implements monitoring programs to ensure compliance
  • Responsible for coordinating those systems necessary for planning, implementing, monitoring and evaluating the hospital’s continued compliance with regulatory standards outlined by federal, state and local statutes
  • Collects, analyzes, and trends regulatory compliance data to assist in the development and implementation of improvement initiatives as appropriate
  • Communicates with senior management and medical staff as necessary to ensure staff is informed on regulatory and safety issues
  • Responsible for coordinating accreditation survey activities and ensuring staff and physicians are knowledgeable as to their survey responsibilities
  • Provides tools to managers, directors and staff for continuous survey readiness
  • Coordinates patient safety programs for orientation, mandatory education and other education as required by applicable regulations
47

Manager Regulatory Compliance Global Compliance MI Resume Examples & Samples

  • Minimum of 5 years proven and progressive financial services operations, compliance or legal experience or equivalent
  • Bachelor’s degree in business, related field or equivalent experience
  • Strong organizational, planning, interpersonal, management, negotiation, consultative and verbal and written communications skills
  • Understanding of all significant regulatory compliance requirements applicable to the assigned business(es) and pertinent Group policies and external regulations affecting their activities
  • Proven ability to accomplish high-level objectives in the context of annual business and compliance plans
48

Finance & Risk-regulatory & Compliance Senior Manager Resume Examples & Samples

  • Minimum 5 years of Risk & Regulatory Compliance experience within the Banking, Capital Markets and/or Insurance industries (e.g., Basel Accord, Dodd Frank, FBO, FINRA, SEC, CCAR, etc.)
  • Minimum 3 years of prior Risk & Regulatory Management Consulting experience focused on the Financial Services industry required. Recent experience highly desirable. Experience must include
  • Solid understanding of front and back office operations
  • FS Risk Operating models and/or Compliance Standards within the Financial Services industry
  • Compliance process design and re-engineering
  • Significant engagement management as well as business, practice, and people development
  • Minimum 3 years of Management Consulting experience focused on Regulatory & Compliance and the Financial Services industry required. Recent experience highly desirable
  • Demonstrated ability to understand client needs, translate business needs into requirements, develop proposed solutions, and deliver high impact change initiatives
  • Demonstrated experience working through organizational change, with a demonstrated track record of continuing responsibilities, creativity and innovation, including evidence of solution design
  • Strong project management skills (e.g., defining scope, setting project timelines and milestones, driving deliverables, identifying risks, and solving issues)
  • Experience leading a project team (sometimes concurrent) of least 3 resources, including an understanding of team strengths, the ability to coach, develop and inspire others
  • Demonstrated insights on key methodologies, approaches and market trends in the industry
  • Strong competence in developing presentations required (MS Office (Word, PowerPoint, Excel))
  • Experience with Risk and/or Compliance technology vendors
  • Prior experience qualifying potential opportunities and negotiating complex deals desirable
  • Demonstrated ability to concurrently handle dynamic consulting workstreams and/or projects
  • Ability to navigate unstructured processes and to simultaneously lead multiple workstreams
  • Ability to work collaboratively and independently while overseeing multiple projects, assignments and/or responsibilities
  • Strong problem-solving and troubleshooting skills with the ability to exercise mature judgment and structured decision-making
49

Manager, Regulatory Compliance Management Resume Examples & Samples

  • Lead and manage the RCM Program including identifying and addressing any process and control gaps, to meet Enterprise RCM Standards and ensure that Wealth remains compliant with regulatory expectations. Provide reporting for global Wealth
  • Responsible for identifying, mapping and documenting all key controls and processes to the regulations inventory for Wealth businesses. For certain businesses, this will include providing oversight with respective business risk functions
  • Manage the Wealth regulations to business control mapping for any ongoing business or regulatory changes
  • Lead stakeholders in the resolution of any material regulatory control gaps/changes and ensure consistency in processes and controls across businesses especially within the same legal entity
  • Execute the regulatory change process for Wealth
  • Review new and proposed regulatory changes, perform gap assessments and identify impacts to Wealth. This includes developing consistent effective procedures to meet regulatory changes
  • Support the completion of ad-hoc regulatory requests and surveys within tight timelines
  • Draft key documents including mandates, policies and associated procedures as required, ensuring appropriate coordination and communication with stakeholders
  • Assess and address impacts and gaps related to any changes in the Compliance Manuals
  • Be a subject matter expert on regulatory compliance requirements and industry best practices related to Wealth businesses
  • Support process improvement initiatives ensuring regulatory compliance requirements and controls are appropriately considered and implemented
  • Establish strong relationships and maintain an interaction model with business partners, WSS colleagues, GAML, Privacy, Legal and Compliance
  • Support ad-hoc analysis and impact assessment on emerging regulatory compliance risks
50

Regulatory Compliance Global Assistant Manager Resume Examples & Samples

  • Subject-matter expert for specific regulation(s), regarding its purpose and legislative history, remaining aware of changes to the regulation or to applicability of the regulation to the business lines in the US. Serves as the central point of contact for US
  • Compliance and oversees the accuracy of the information regarding the regulation in the risk assessment tools while serving as the advocate for consistency for controls
  • Internal Audits and provides input into the action plans to address any weaknesses identified. Ensures remediation efforts are on track for assigned regulation(s), regulatory requirements and/or compliance risks
  • Five to seven years proven and progressive regulatory compliance and/or legal management experience or equivalent
  • Knowledge of regulatory state licensing and registration requirements a plus
  • Proven experience managing regulatory relationships and examination management experience
  • Strong communications, analytical, interpersonal, organizational, project management, document production and planning skills
51

Manager, Regulatory Compliance & Toxicology Resume Examples & Samples

  • Initiate the creation of EU PIF documentation including authoring and approving CPSA sections 1 and 2 for use in international markets for registration of products
  • Coordinates specifically with international distributors to ensure that they have the necessary documentation to properly register the product in the distributors’ jurisdiction with necessary government agencies such as the Ministry of Health in the country or countries the distributor sells to
  • Assists in the updating of the internal formulation database to include all necessary hazard and safety information on individual chemicals used (by CAS number) in Hain product to assure that accurate Safety Data Sheets can be produced for all products manufactured. Additionally working with third party co-packers to obtain sufficient information to populate this database with information on the materials manufactured by these third parties
  • Acts as the internal toxicological expert to assist the corporation more generally in all aspects of the business, including but not limited to, claims support, substantiation of claims, and review of materials for other groups such as the food teams
  • Works with Package Engineers and Purchasing personnel to ensure that there is sufficient information on the primary packaging materials to fulfill all requirements from the international community where Hain products are sold (EU, Asia, LatAm, Middle East) regarding such topics as the materials used and potential of packaging materials leaching into the product
  • Bachelor’s degree required in either toxicology or closely related science required; Graduate degree and current Cosmetic Product Safety Assessor accreditation strongly preferred
  • Knowledge of the requirements for documenting items in international jurisdictions where Company’s products are currently sold (i.e.)
  • Excellent organizational skills, ability to prioritize multiple priorities and strong attention to detail
  • Computer skills including MS Office programs such as Outlook, Word, Excel PowerPoint
  • Strong interpersonal skills and ability to communicate (verbal/writing) effectively
  • Self-motivated and strong analytical / problem solving skills
  • Ability to collaborate at all levels of the organization and across other functional areas, including multidisciplinary international teams
  • Ability to maintain a high level of confidentiality
  • Preferred knowledge of the Consumer Product Goods Industry
  • Work with minimal supervision execute for results in a fast paced environment
  • Ability to empower, motivate and inspire staff
  • Previous supervisory experience a plus
  • Ability to lead change and execute on strategic decisions
52

VP Regulatory Compliance Global Manager Resume Examples & Samples

  • Knowledgeable about the results of any relevant BRCM reviews, CTAC testing and
  • Articulates any control weaknesses and status of plans to address these across HNAH
  • Initially, this information will be part of the RCR Controls remediation Project for each regulation
  • 7+ years proven audit, compliance, financial services and/or regulatory experience, or equivalent
  • Minimum of a Bachelor’s degree in business, related field or equivalent experience
  • Master’s degree and/or Juris Doctorate (JD) preferred
  • Proficiency with personal
53

AVP Manager Regulatory Compliance Resume Examples & Samples

  • Under the direction of a more senior officer, serves as a subject-matter expert for specific regulation(s), regarding its purpose and legislative history, remaining aware of changes to the regulation or to applicability of the regulation to the business lines in the US
  • Is knowledgeable about the results of any relevant BRCM reviews, CTAC testing and Internal Audits and provides input into the action plans to address any weaknesses identified. Provides support to ensure remediation efforts are on track for assigned regulation(s), regulatory requirements and/or compliance risks
  • Assists management in articulating any control weaknesses and status of plans to address these across HNAH. Initially, this information will be part of the Regulatory Controls Review (RCR) Controls Remediation Project for each regulation
  • This role typically reports to a VP or SVP level regulatory compliance officer. In some cases, this role may report to an AVP Manager Regulatory Compliance Officer
  • Minimum of three to five years proven and progressive financial services, compliance and/or legal management experience, or equivalent
  • Well-developed communications, analytical, organizational, and project management skills
  • Broad scope of knowledge of assigned businesses, including products, operations, systems, and organization and thorough understanding of significant regulatory compliance requirements applicable to assigned business(es)
54

Manager, Regulatory Compliance Resume Examples & Samples

  • The Regulatory Compliance Manager is responsible for the management of the Compliance of the Allentown facilities to the US, EU, HealthCanda regulations. Provides oversight to and is directly responsible for the results of a team of compliance personnel
  • Support Regulatory agencies and Client Audits, assist with responses and trending of observations
  • Member of the NA Audit Team, assist with supplier audits in support of FCS NA and other FCS sites as needed
  • Approve Customer compliance related correspondence
  • Oversee the self inspection activities
  • Maintain Regulatory Licenses (FDA, DEA,VAWD)
  • Ensure regulatory compliance for the site in policies, procedures, and regulatory requirements
  • Develop, maintain, and monitor regulatory/compliance SOP’s
  • Provide or assist on employee training to ensure compliance with procedures and regulations
  • Oversight of DEA activities
  • Other duties and special projects may be assigned to meet business needs
  • Bachelor degree (B.A./ B.S.) from a four-year college or university required
  • A minimum of 8 years of experience in the Pharmaceutical/Medical Device or Regulated industry with at least 5 years of direct management experience required
  • Experience with Quality Systems (audits, recalls, deviations, complaint management, documentation management, etc) in a pharmaceutical or applicable regulated environment
  • Familiarity with applicable CFR, cGMP, QSR, ISO, ICH and Health Canada standards/regulations
  • Effective communication skills to interact with employees in all departments of the organization including, but not limited to, managers, senior management, customers, vendors, and regulatory agencies
  • Travel is required to audit supplier locations and other FCS sites as necessary; overnight travel approximately 10%
  • May be required to travel domestically and internationally
  • Ability to manage multiple tasks and meet deadlines, work under pressure in a fast paced environment
  • Ability to walk and work in Operational area as required
  • Applies Good Manufacturing Principles in all areas of responsibility
  • Demonstrates and promotes the company vision
  • Ability to lift 10 to 20 pounds
  • Support other related tasks as required
  • IND-CCG
  • LI-CCG
55

Manager, Regulatory Compliance Resume Examples & Samples

  • Knowledge of organic chemistry
  • Working knowledge of SAP regulatory functions and related regulatory databases
  • Five years experience working in a regulatory environment for the chemical industry
  • Experience working with regulatory agencies and trade associations
  • Advance degree in Chemistry, Polymer Science, or similar field
  • Five to ten years current experience working with SAP regulatory functions and related regulatory databases
  • Prior experience working in a chemical regulatory function with global responsibilities
  • Prior experience in registering chemical substances globally
  • Developing strategies for commercialization and globalization of product lines
  • Minimum Educational Level of a BS/BA
  • Experience level of 5-8 years
56

Manager, Nutrition & Regulatory Compliance Resume Examples & Samples

  • Developing nutrient and ingredient labelling information for Kellogg Canada products in compliance with government regulations, policies and company guidelines: includes compiling and issuing the Nutrition Facts table (NFt) and ingredient list, as well as collecting and/or validating formula nutrient analyses, NFt format, product piece weights, cup density, allergen information, kosher status and any other required information for nutrition labelling. Requires verifying and approving ingredient information and recipes within the SAP formulation database
  • Collaborating with Marketing and Legal to develop product nutrition claim and naming justifications, ensuring compliance with all government food and nutrition regulations. Includes developing substantiations for claims, as needed
  • Working with the Canadian Innovation team, Launch Program Managers and Product Developers to bring new innovation projects to the marketplace, as well as assessing products from US and other countries to ensure compliance with Canadian food and nutrition regulations and policies
  • Participating in an internal review process to approve of all food, nutrition and quality related claims on packaging, scripts, internet and other promotional materials
  • Providing support for novel food/ingredient government applications, global position papers, and nutrition science-related regulatory matters (e.g., fortification) and other related nutrition regulatory needs
  • Providing support for Kellogg North America and Global requests, including, but not limited to product renovations, the development of nutrition labelling procedures and special projects pertaining to nutrient data analysis
  • Providing support to answer consumer, sales and marketing nutrition and ingredient inquiries
  • Responding to Health Canada and CFIA requests for feedback on regulatory and policy amendments/change
  • Bachelor in Food Science, Nutrition or related field
  • Significant demonstrated experience in a nutrition and regulatory role
  • Must have excellent knowledge and application of food labeling and advertising regulations in Canada, as well as experience with food formulations and ingredient specifications
  • Demonstrated analytical, organizational, team work and communication skills
  • Proven orientation to results and solutions, and the ability to manage competing priorities to provide information in a timely manner
  • Proficient in all Microsoft Office Applications
57

Manager, Regulatory Compliance Resume Examples & Samples

  • Identify and prioritize key risk areas
  • Manage health plan regulatory compliance team
  • Ensure state licenses are up to date and renewed properly and timely
  • Implement compliance plan
  • Track and implement legal and regulatory requirements related to the assigned subject matter or business areas
  • Utilize industry groups and research technology sources for retrieving legal and regulatory provider requirements
  • Deliver accurate, detailed and timely analysis and of new laws and regulations impacting the health plan operations to build and maintain compliance and avoid the potential for risk exposure
  • Consult with business to support continuous operational improvements into daily business practice
  • Assist in maintaining compliance reporting
  • Participates in health plan compliance reviews
  • Work with senior leaders to develop compliance action plans
  • Proven ability to maintain confidential communications
  • Strong organizational and technical skills
  • Minimum of 6 years in healthcare compliance with health plan compliance preferred
58

Manager, Regulatory Compliance Resume Examples & Samples

  • Manage and maintain the Program, working with the Compliance Analytics and Testing team, but is not limited to: Developing compliance testing plans/schedules for the different lines of business, utilizing a risk based approach with multiple inputs and in consultation with personnel in multiple areas – Regulatory Compliance, business unit compliance and other control areas such as internal audit
  • Conducting compliance testing of processes and controls implemented by the various business units for compliance with regulatory requirements and internal policies, including fraud risk management
  • Documenting and presenting testing results to business management and compliance. Reviewing action plans for adequacy and performing follow-up testing on the implemented action plans
  • Completing regular reporting on compliance testing results
  • Reviewing Program outcomes for trends and opportunities for improvement of risk management and program effectiveness
  • Perform monitoring and quality assurance of AML/ATF procedures. This includes, but is not limited to
  • Performing monitoring and developing/enhancing procedures for monitoring adequacy of, adherence to, and effectiveness of day-to-day compliance procedures
  • Assessing, documenting and presenting monitoring results to compliance management and business units as appropriate
  • Provide functional support to the Director. This includes, but is not limited to
  • Assisting the Director to resolve escalated regulatory compliance issues in a timely manner
  • Assisting the Director with various reporting and certification processes
  • A minimum of 4-7 years of progressive experience in regulatory compliance or governance, risk management or other control functions and a solid experience in internal auditing or operational/business controls testing within the financial services industry
  • Good knowledge of the business operations of Sun Life Financial and particularly Sun Life Financial Canada or the financial services industry. Excellent knowledge of risks and controls and testing methodology
  • Highly developed written and oral communication skills. Ability to communicate to all levels of an organization
  • Strong analytical, organizational and problem solving skills
  • Ability to work independently as well as in a team and manage multiple priorities and timelines
  • Experience working with diverse business lines is preferred
59

Finance & Risk Regulatory & Compliance Senior Manager Resume Examples & Samples

  • Minimum of 5 years of recent Risk & Regulatory Management Consulting experience from a top tier consultancy focused on the Financial Services industry. Experience should include
  • A strong desire to deliver to a high standard and ability to develop creative and breakthrough solutions
  • Demonstrated ability to navigate unstructured processes and to concurrently manage large consulting workstreams and/or projects
  • Ability to work collaboratively and independently while managing multiple projects, assignments and/or responsibilities
60

Manager, IT Regulatory Compliance Resume Examples & Samples

  • Leads and executes supplier audits, covering GxP related software and technology service providers, including suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS), Software as a Medical Device (SaMD), and Mobile Medical Apps (MMaps)
  • Determines and documents adherence to Johnson & Johnson enterprise standard operating procedures and regulatory requirements and identifies and communicates compliance related issues, including the risk criticality of each issue; the validated status of systems; and the rating/classification of suppliers
  • Communicates compliance gaps, considering big picture risks, and gains business partner commitment to address issues found during audits. Authors audit reports and documents observations and commitments clearly, accurately and timely to enable tracking verification
  • Utilizes expert knowledge of regulations and risk management concepts to ensure compliance with local and global regulations
  • Supports Health Authority inspection readiness activities ensuring technical subject matter expert preparedness and interacts with regulators on matters related to IT processes, computer system validation, and other technical topics
  • Participates in gap assessments to new or evolving regulatory requirements and guidances
  • Partners with other compliance groups (J&J Regulatory Compliance/R&D Compliance/Corporate Internal Audit) as needed on for auditing and remediation activities
  • Builds and maintains trusting, collaborative relationships and partnerships with internal stakeholders to accomplish business objectives
  • Participates in industry and other professional networks to ensure awareness of industry standards, trends and best practices to strengthen GxP audit knowledge
  • Identifies potential risks, articulates impact, and gains alignment from business partners to establish proactive risk mitigation strategies
  • Applies knowledge of current and emerging regulatory trends to continuously improve audit programs
  • A minimum of a Bachelor’s Degree is required. An advanced degree is preferred
  • 5+ years of progressive experience in the pharmaceutical/ medical device/ biotech industry required
  • 3+ years leading and executing audits of computerized systems (software and infrastructure) required
  • Expert knowledge of GxP regulations; including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems required
  • Expert knowledge of leading practices including but not limited to; GAMP5, ISO-9001, ISO-27001, NIST, etc. required
  • Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood by others is required
  • Experience interacting or supporting health authorities and/ or notified bodies during inspections is preferred
  • CISA, ASQ, ISO Lead auditor or other auditor certification preferred
  • This position may require approximately 30% domestic/international travel
61

Product Safety & Regulatory Compliance Team Manager Resume Examples & Samples

  • Take responsibility for ITBA Product Safety organization and coordination
  • Take responsibility for Nacka unit specific product safety routines and procedures
  • Perform product safety and regulatory compliance reviews
  • Review new and changed international legislation, directives and standards, make interpretations as needed, create policies and transform the result into clear product requirements for different product families
  • Advise and assist Product Development Projects, Engineering and Marketing in certification, declaration and environment issues
  • Assist production units at inspections, and advice regarding needed improvements and changes
  • Define product labeling and documentation requirements from a regulatory perspective
  • Discuss local regulatory demands with customer centers globally, and assist in solving issues
  • Maintain routines and subscriptions to make external standards available for all industrial technique business area units
  • Coordinate and drive product related standardization activities within the company
  • Actively drive eco design initiatives according to regulatory requirements, company sustainability targets and customer expectations
  • You need an Engineering background and education, mechanical or electrical
  • You need knowledge and experience in working with product safety, directives, standards and certification. Environmental experience is an advantage
  • To be successful in discussions with different stake holders globally, you need to be good at English speaking, understanding and writing
  • Management experience is required, either as line manager or project manager
62

Regulatory Trade Compliance Manager Resume Examples & Samples

  • Develop responses to CF28/CF29 and Notice of Action responses
  • Support various new product and projects teams
  • Participate in the on boarding of new business units
  • Minimum 5 years relevant experience in Trade Compliance Management required
  • Demonstrates expertise in customs issues and issue resolution request is also required
  • Expertise in classification of goods under the Harmonized Tariff Classification and Schedule B
  • Comprehensive understanding of US Customs procedures; ITAR, BIS and EAR,
  • Strong computed skills in Oracle, MS Office and OBIEE
63

Manager, Regulatory Compliance Resume Examples & Samples

  • Service contract, portable electronic insurance, and ancillary product and program development and implementation
  • Review marketing and advertising materials, program changes and other customer communications to ensure regulatory compliance, including consumer protection and corporate policy guideline compliance
  • Analyze and stay current with state and federal laws and regulations for insurance, service contract, and procedures, consumer protection requirements and insurance licensing and reporting requirements
  • Draft service contract forms, and collect information necessary to prepare regulatory filings and any other forms required by regulators, including state departments of insurance
  • Serve as a liaison and information source to client services and project teams including clearly articulating core principles and legal or regulatory constraints that must be satisfied
  • May coordinate program and product development with other compliance functions, including licensing
  • May conduct research projects with inside resources
  • Establish strong collaborative relationships with cross functional team, including underwriting, finance, marketing and product development
  • Have functional understanding of the company’s risk profile and the impact of product decisions on the company’s core financial performance
  • Actively seek operational understanding and implications of initiatives
  • Four-year college degree
  • Aptitude and motivation for staying current with regulatory changes in insurance, service contract, and consumer protection regulations
  • Able to understand detailed documents and effectively communicate information to others
  • Demonstrates ability to effectively understand, consider and address the client or business while mitigating risk exposure
  • Able to keep multiple projects and initiatives organized and moving forward in a fast-paced environment
  • Schedules and prioritizes work and deliverables to ensure on-time response to large variety of changing demands/requests/requirements
  • Professional interpersonal and organizational skills, and experienced at communicating with colleagues at various levels of the organization
  • Previous regulatory compliance or insurance, service contract and consumer protection experience will be considered a plus
  • Legal research and analysis training or experience a plus
  • Must be highly proficient with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, and usage of the Internet
64

Regulatory Compliance Analytics Manager Resume Examples & Samples

  • Bachelor’s Degree in Economics, Finance, Statistics, Mathematics, Computer Science, Management Information Systems, Engineering, Business Analytics disciplines, or related area
  • 4+ years of experience with data quality analysis, statistical analysis and/or modeling, financial or cost analysis, internal controls, and/or external/internal financial audit
  • 2+ years in a technical or functional lead role
  • Experience mining and analyzing transactional electronic data with competency in one or more of the following: SAS, SQL, SPSS, R, Python, ACP, IDEA Tableau, MATLAB, Visual Basic, Business Intelligence, Hadoop or Alteryx
  • Experience mentoring and coaching others
  • Proven leadership skills demonstrating strong judgment, problem-solving, and decision-making abilities
  • Experience managing senior-level client relationships
  • Experience presenting to clients or other decision makers to present and sell ideas to various audiences (technical and non-technical)
  • Pre-sales, proposal, and RFP experience
  • Must be able to obtain and maintain required clearance for this role
65

Regulatory Audits Compliance Manager Resume Examples & Samples

  • Oversee staff who coordinate all aspects of regulatory audits
  • Developing and coach the team
  • Conduct staff performance evaluations
  • Develop work plans, policies, procedures and workflows for the team
  • Train new employees on policies, procedures and workflows for the team
  • Manage multiple projects and collaborate across multiple business segments
  • Act as a gatekeeper for regulatory audits
  • Guide staff in coordinating all aspects of regulatory audits (i.e., pre - site deliverables, mock audits, on - site visits and logistics, written responses to audit reports)
  • Assist staff in working with various internal groups to gather needed information for regulatory audits
  • Manage the tracking and reporting mechanism for regulatory audits
  • Manage, track and report regulatory audit activities
  • Develop and present reports and results of regulatory audits for organizational review
  • Develop and lead training and education on regulatory audit- and compliance - related topics
  • Manage a compliance function that monitors compliance with state, local and federal legislation which meets the best business practice standards in health care
  • Develop and implementing policies, procedures, structures and processes to meet regulatory audit requirements
  • Use and continue to develop Medicare, Medicaid and Commercial product knowledge to address regulatory audit issues accordingly
  • Educate Medicare, Medicaid and Commercial business partners on Medicare, Medicaid and Commercial regulatory audit processes
  • 5+ years of experience in compliance, privacy and / or regulatory affairs or with supporting audits in a highly regulated industry; preferably a government, health care or managed care environment
  • 3+ years supervisory experience
66

Regulatory Planning & Compliance Manager Resume Examples & Samples

  • Single Point of Contact (SPOC) for Global CMC and Labeling CoE to disseminate variation updates for RMC and Local operating Company
  • Manage milestone planning for Local operating Company & RMC team
  • Optimize and maintain planning/managing tool and provide oversight to Local operating Company
  • Collaborate pro-actively with Global, RMC team and Local operating Company for priority changes or potential compliance risk
  • Supports in the set-up of the RMC and onboarding of the LOCs
  • Optimize and maintain the RMC planning tool
  • Embeds the planning process in the region and drives continuous improvement
  • Collect input from involved Global, Regional, Local regulatory teams
  • Drive integrated planning process by engaging RA stakeholders to ensure insight on all inputs
  • Identifies gaps / areas for clarification (with CMC & Global Labeling, LOC, RMC team members)
  • Take action to close these gaps in liaison with Global, Regional, Local and RMC regulatory teams
  • Monitor resource planning and pro-actively act on potential conflicts
  • Monitor milestone planning and report to RMC head, Local, Regional, and Global regulatory teams
  • Create resource report (overview) for RMC
  • Single point of contact for Global (CMC RA and Labeling CoE) to align on planning, address prioritization and escalation in case of potentiation compliance risks
  • Collaborate with RMC Professionals and dossier leads on dossiers in scope, in case of priority changes or potential compliance risks
  • Ensure compliance with submission and approval deadlines
  • Business acumen (Applying): Leverages knowledge of the sector, organization, Regulatory Affairs function, and cross-functional business partners to make informed business decisions and create and execute business strategies. Assesses the impact of current regulatory requirements on the business to assist in the development of innovative Regulatory strategies and/or innovative ways to execute them. Executes results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Manages projects within timeline requirements
  • Decision Making & Priority (Leading): Clearly defines and prioritizes decision criteria and considers benefits and risks of each decision and its immediate and future implications. Considers all of the available facts when situations are ambiguous in order to make the best possible decision. Manages multiple and changing priorities based on factors such as time constraints, urgency, and business need. Manages complex or ambiguous situations including integration of large amounts of changing, complex, or ambiguous information. Navigates a complex organizational structure to make effective, complex decisions and achieve strategic and/or project goals
  • Leading & Influencing (Applying): Leverages an understanding of others’ motivations, needs, and concerns to establish trust and credibility and influence others. Demonstrates conviction, proactivity and persistence when influencing internal and external stakeholders with or without direct authority or formalized structure. Creates compelling negotiating positions that build support and consensus among key stakeholders. Leverages internal networks to enhance collaboration, information sharing, and form strategic partnerships
  • Persuasive Communication (Leading): Delivers and creates tailored communications and presentations that educate and mobilize critical stakeholders and translates complex information into key facts and rational arguments that are influential, meaningful, and actionable. Fully engages others by asking incisive and thought provoking questions, always ensuring mutual understanding. Develops written technical communications that are influential, meaningful, and tailored to the audience and business need, including translating complex or technical information into simplified explanations to promote understanding
  • SPOC for planning, prioritization, progress reporting and escalation
  • Close collaboration with peers in the other regions
  • Comprehensive understanding of the needs of global and regional business partners
  • Good negotiating skills to ensure agreement with global and regional teams on planning and expected services
  • Understanding of compliance requirements and ability to influence outcomes
  • Minimum Bachelors’ degree in pharmacy, life sciences or equivalent field
  • Minimum of 5 years of project management / resource planning experience
  • Minimum of 3 years of regulatory experience
  • Demonstrated organizational skills, complex project management skills, as well as experience working in a matrix organization
  • Knowledge of local and regional regulations/legislation (preferred)
  • Experience in working with limited supervision and able to make independent decisions
  • Excellent verbal and written communication skills – proficiency in written and oral English
  • Ability to communicate to senior level management
  • Cultural sensitivity and ability to work and thrive in a multi-cultural environment
  • Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment
  • Proficient use of technology including planning, compliance and resource systems
67

Regulatory Compliance Services Senior Project Manager Resume Examples & Samples

  • Air permitting and compliance
  • EPCRA
  • Stormwater
  • TRI reporting
  • Identifies clients in need of consulting expertise and markets the services of the company to those clients; develop constructive and cooperative working relationships that can be maintained over time
  • Participates in the development of marketing strategies and formal presentations of qualifications to clients on various projects in area of expertise
  • Coordinate and manage regulatory compliance projects, assign and evaluate work
  • Works with clients and colleagues to define project scope, schedule and budget
  • Identify, develop, and gather the resources to complete the project. This may include preparing calculations, designs, reports and work specifications; developing project schedules, budgets and forecasts; and selecting materials, equipment, project staff, and external contractors
  • Conduct meetings and prepare reports to communicate the status of the project
  • Lead team safety efforts and promote safety rules and guidelines. Responsible for creating and modeling a safe work environment; champion safe practices. Foster pre-task planning for all projects
  • Conduct quality-assurance reviews of project-related documents; promote continuous quality monitoring and improvement on projects. Monitor quality standards and practices
  • Serve on teams conducting environmental assessments of client facilities, providing assistance with planning, quality assurance, and safety protocols
68

Manager, Regulatory Compliance Resume Examples & Samples

  • Serve as a focal point within the company and externally for the regulatory compliance program
  • Apply expert level knowledge of the Cost Accounting Standards (CAS), Generally Accepted Accounting Principles (GAAP), the Federal Acquisition Regulation (FAR) cost principles, and DFARS contractor business systems to facilitate and resolve ongoing audits
  • Lead your team to prepare the contractor’s response to contract audit reports and provide audit support documentation to auditors in their audits to result in minimal findings and successfully resolve questions to support Engility Corporation
  • Prepare the annual incurred cost audit submissions within the required timeframes
  • Streamline processes and procedures where possible to increase staff productivity
  • Manage and train junior staff members to successfully complete assigned projects, with the goal to advance staff to more complex assignments
  • Prepare Cumulative Allowable Cost Worksheets for closeout
  • Schedule and lead periodic meetings with the Defense Contract Management Agency (DCMA), Defense Contract Audit Agency (DCAA), and Engility’s DACO
  • Leverage a variety of electronic business and software tools to obtain, organize, and present relevant business data for management
  • Have attention to detail to provide quality submissions resulting in minimal findings and/or questions
  • Be a student of continuous learning to stay abreast of developing policy changes and developing industry trends related to contract compliance standards, regulations and legislation
  • Enjoy the challenge of competing priorities and have the ability to multi-task
  • Bachelor's degree in Accounting, Finance or a related field
  • 4 to 10 years of relevant experience with federal government contract accounting or regulatory compliance
  • Possess relevant knowledge of Cost Accounting Standards (CAS), Generally Accepted Accounting Principles (GAAP), the Federal Acquisition Regulation (FAR) cost principles, DFARS contractor business systems requirements and their applicability to a government contractor
  • Previous managerial / supervisory experience, or mentor relationship
  • O A Certified Public Accountant and/or advanced degree
69

Manager, Regulatory Compliance Testing Resume Examples & Samples

  • Provide regulatory and control guidance regarding business practices, key decisions, policies, processes and, standards
  • Support the strategic operations program for the development of a culture of risk and compliance through the enhancement and execution of monitoring reviews associated with higher risk regulations and reporting of findings
  • Provide effective challenge to the 1st LoD and guidance on organizational risks and controls as needed
  • Assess operational breakdowns for compliance risk and provide guidance on remediation/recovery plans
  • Provide guidance on controls over compliance requirements and business line monitoring of those controls
  • Perform risk-based reviews of business line control design and execution effectiveness and provide guidance on identified risks or gaps
  • Develop review procedures, including tools/templates necessary to complete reviews (i.e. review check list, official report of review, etc.)
  • Work closely with the Lines of Business (“LoB”) to understand risk points and key challenges within the 1st LoD as well as documentation of any related issues noted during the review
  • Ensure review plans are completed in a timely and accurate manner
  • Identify requirements to provide direction for the technical build out and/or support of databases, queries, reporting tools, dashboards, etc. that enable analysis and complete and accurate reporting for the Strategic Operations Governance and Oversight team
  • Stay abreast of industry emerging trends pertinent to SC to facilitate a more proactive approach to risk identification and mitigation
  • Responsible for staying abreast of regulatory issues, developments, changes and evaluating impact on applicable areas, collaborating with Director and the LoB on implementation and risk mitigation efforts
  • Works with management to determine scope and examination techniques required to assess the control reviews for the area
  • Contacts business management to identify areas needing review and to arrange examination steps and timetable
  • Reviews a variety of documentation, examines methods and systems, and interviews personnel to obtain information on actual practice
  • Compares practice with regulatory and internal requirements to identify variances
  • Determines areas where corrective action is required
  • Prepares written reports / memorandums on review findings and recommendations
  • Performs reviews independently as needed or in conjunction with other assigned personnel, acting in a lead capacity
  • Discusses and validates findings with management
  • Prepares and presents conclusions and recommendations to management
  • Stays current on company policy and regulations impacting company business
  • Special projects as requested including internal investigations and consultancy work
  • Professional certification (CRCM, CIA, and / or CCSA)
  • Juris Doctorate (JD)
  • Five (5) years of Auto lending / leasing compliance experience
  • Three (3) years of experience as a Compliance Consultant, Compliance Examiner with a Regulatory agency, Regulatory Compliance Attorney, etc
70

RC Regulatory Compliance Senior Manager Surveillance Assurance & Validation Resume Examples & Samples

  • Sets priorities and makes day-to-day decisions independently. Escalates matters to senior management as needed
  • Is knowledgeable about the results of any relevant BRCM reviews, CTAC testing and Internal Audits and provides input into the action plans to address any weaknesses identified. Ensures remediation efforts are on track for assigned regulation(s), regulatory requirements and/or compliance risks
  • Articulates any control weaknesses and status of plans to address these across HNAH. Initially, this information will be part of the Regulatory Controls Review (RCR) Controls remediation Project for each regulation
  • Typically works under the direction of the SVP Regulatory Compliance or VP Director Regulatory Compliance. May be responsible for the management of AVP Regulatory Compliance and Regulatory Compliance Officer staff
  • Minimum of seven years proven and progressive financial services, compliance, and/or legal management experience, or equivalent
  • Minimum of a Bachelor’s degree in business, related field or equivalent experience
  • Supervisor/management experience preferred
  • Proficiency with Big Data and software packages including Microsoft Excel, Word, and PowerPoint
71

Regulatory Compliance & Environmental Manager Resume Examples & Samples

  • Manage a central team of multi-media regulatory compliance and environmental professionals to assist in managing the accountabilities described below
  • Coordinate with BU HSE Managers and BU leadership to manage environmental compliance programs in the Lower 48 that comply with state and federal laws and maintain conformance with BP corporate requirements
  • Provide strategic technical guidance and environmental permitting support to the Lower 48 business units to enable the achievement of their business objectives
  • Lead environmental initiatives and participate in deploying programs on key environmental matters including access, greenhouse gas emissions, environmental management systems (EMS), sustainability and proactive compliance auditing
  • Manage environmental compliance audits, the findings and specific audit actions to closure
  • Coordinate with the BU HSE Managers and the L48 Risk lead to manage the maintenance of the L48 regulatory compliance and environmental risks, using the BP risk processes
  • Optimize the use of environmental consultants used by operations and develop cost control methods, quality standards and scheduling requirements to ensure efficient use of environmental consultants
  • Manage with the L48 Business Development team and central Mergers and Acquisition team the environmental due diligence for acquisitions and environmental disclosures for divestitures
  • Coordinate with the BU HSE Managers and BU LT’s to respond to or support the response to environmental claims such as new lawsuits, complaints, and Notices of Violation
  • Work with BU HSE Managers, BU leadership and L48 Government & Public Affairs on environmental issues raised by regulatory agencies and the communities in which we operate
  • Support the manager of L48 Land, BU HSE Managers and BU leadership (as necessary) to coordinate with BP Remediation Management to manage new or legacy L48 environmental cleanup matters to closure
  • Collaborate and coordinate with L48 Public & Government Affairs and the BP America Communications and External Affairs organization on the development of advocacy strategy and strategy execution for new and emerging regulations that have the potential to impact BP L48 activities
  • Coordinate with the BU HSE Managers and BU leadership on the effective implementation of newly finalized environmental regulations impacting L48 operations
  • Collaborate and coordinate with the BP Upstream and Group SOR/RC&E organizations on matters that are important to BP and that require coordination with the L48 business
  • Minimum of 15 years of experience in the oil and gas industry
  • High technical proficiency in the comprehension and application of the applicable regulatory resources and requirements associated with environmental compliance and sustainability
  • Proficiency communicating regulations, risk management, and risk assessment skills
  • Proficiency in HSE auditing, incident investigation, and documentation techniques
  • Proficiency with written and email communication including use of MS Office (Word, Excel, etc.)
  • Excellent interpersonal and relationship building skills to work effectively with all levels of leadership, professional staff, and field employees
  • Excellent interpersonal and relationship building skills to work effectively with external stakeholders
  • Excellent verbal and written communication skills which include the ability to present information, speak, write and listen in a manner that clarifies issues, promotes closure and delivers information in a clear and concise manner and facilitates good decision-making is required
72

Manager Regulatory Compliance Commercial Banking Global Liquidity & Cash Management Resume Examples & Samples

  • 3 - 5 years of experience in Regulatory Compliance, with relevant Commercial Banking business line exposure. Alternatively 5-7 years expereince in GLCM/PCM with demonstrable progressive development including Senior Client Service or Middle Office experience with judgement relied upon by Senior Management
  • Strong communication and inter-personal skills, with experience of dealing with indivuals at all levels including the capacity to articulate the case for risk management and policy in the language of business
  • Understanding of dealing with regulatory matters and interaction with Regulators
  • Ability to influence change and contribute to joining up with the other teams in Risk and Business globally
73

Technical Manager Regulatory Compliance Resume Examples & Samples

  • Analysis of regulatory requirements and developing procedures and processes for ensuring compliance with the overall goal of eliminating any potential for violations and civil or criminal penalties, and
  • Compliance related support for ongoing operations and new projects, and the development and implementation of compliance related broad initiatives, strategies and policies
  • Supports compliance assurance across gas pipelines and processing in Canada
  • Incumbent will remain accountable for legacy responsibilities for Enbridge’s compliance with the Line 6B Consent Decree
  • Resolves compliance issues by developing stakeholder consensus; and implements initiatives, procedures and policies
  • Provides general compliance assurance supports to all Canadian gas pipelines and processing departments, including support for new projects, acquisitions and joint ventures
  • Facilitates excellence through support of committees
  • Advises senior management compliance initiatives and develops plans for ensuring compliance
  • As directed, may support or lead communications with Regulators
  • Ensures required compliance reporting in a timely manner
  • Works with various departments to identify and mitigate compliance risks
  • Supports compliance reviews across departments
  • University degree in Engineering, or a related discipline is required
  • A minimum of 10 or more years of progressively responsible experience in compliance management, law, regulatory affairs, operations and/or Engineering is required
  • Excellent communication and interpersonal skills to interact with a variety of stakeholders will be critical
  • Salary and job level will be commensurate with qualifications and experience
74

Regulatory Compliance Legal Senior Manager Resume Examples & Samples

  • Minimum of 10 years (CL7) or 15 years (CL6) of experience as an attorney providing services and regulatory compliance advices to the industry, including experience as a transactional attorney and at least 4 of which involved management responsibility for other legal professionals
  • Expertise: regulatory compliance expertise in various regulated areas within his remit
  • Good judgment, an ability to prioritize and make decisions, and a high level of common sense, including the ability to see around the corner and spot risks before they materialize
  • Legal Advisory Acumen
  • Legal Regulatory Compliance Acumen related to products and/or services
75

Manager Regulatory Compliance Resume Examples & Samples

  • 5 - 10 years of quality assurance experience in the medical device or pharmaceutical industry
  • Demonstrated ability to lead and influence others
  • Experienced in reviewing materials for compliance to regulations and market approvals/clearances
  • Ability to develop and maintain strong relationships in furtherance of quality goals and objectives
  • Excellent team building and leadership skills that motivate team members to drive projects to a successful conclusion; must be able to manage and lead without direct authority
  • Excellent judgment skills in order to provide strong guidance and counsel to staff
  • Extensive knowledge of medical device regulations
  • Time management skills for oneself and of others on a team, ability to drive projects to scheduled completion
  • Superior interpersonal, verbal and written communication skills
  • Exceptional organizational, negotiation, and problem solving skills
  • Must be able to manage and lead without direct authority
  • Ability to work in a matrixed organizational structure, developing strong relationships with all levels of management
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Offerings & Services Regulatory Compliance Counsel Senior Manager Resume Examples & Samples

  • Offerings and services regulatory risk assessment
  • JD or equivalent law degree (based on geography) required with tenure in good standing with one state bar
  • Compliance Legal Counsel & Support
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Financial Institutions Regulatory Compliance Senior Manager Resume Examples & Samples

  • 8-15 years of recent or current experience in financial institutions regulatory compliance
  • Consulting/professional services experience required
  • Bachelors’ Degree required
  • CRCM certification required
  • Experience with business development required
  • Experience developing and presenting industry related thought leadership preferred
  • Candidates must be well versed in alphabet regulations and BSA
  • Up to 60% travel (predominately in the great lakes region)