Regulatory Counsel Resume Sample
Hazel Buckridge
888 Hagenes Greens,
Dallas,
TX
+1 (555) 101 7968
Work Experience
Senior Regulatory Counsel
02/2018
-
PRESENT
San Francisco, CA
- Juggle and successfully prioritize competing and voluminous work streams simultaneously
- Function as a key member of the GEH Legal & Compliance (L&C) Organization
- Provide day-to-day nuclear regulatory counsel and related assistance to GEH and its affiliated nuclear businesses
- Apprise and consult GEH General Counsel, as appropriate
- Investigate nuclear regulatory issues raised or referred to L&C, internally or externally, generate investigative reports / responses, and recommend appropriate corrective action
- Represent the company and its personnel in connection with regulatory investigations conducted by NRC, DOL, or other governmental agency
- Prepare regulatory submittals
Regulatory Counsel
11/2015
-
12/2017
New York, NY
- Provide legal advice to business leaders in responding to licensing and enforcement proceedings, including preparation for and participation in NRC regulatory conferences
- Conduct the day-to-day operation of the global Nuclear Ombuds Program; Implement robust Nuclear Ombuds Program framework, including but not limited to the following
- Function as a key member of the Legal & Compliance organization, reporting directly into the GEH General Counsel
- Provide nuclear regulatory advice and related assistance to GEH and its affiliated global nuclear businesses
- Perform nuclear regulatory related due diligence in support of business development opportunities
- Investigate nuclear regulatory issues, as they arise; prepare investigative reports and regulatory responses; and make recommendations to business and functional leadership re: preventive and corrective action plans
- Represent the company and its personnel during regulatory investigations conducted by NRC, DOL, or other governmental agency; Prepare regulatory submittals in connection therewith
Markets Regulatory Counsel
07/2011
-
05/2015
Chicago, IL
- Serve as legal advisor to business leaders in responding to licensing and enforcement proceedings, including preparation for and participation in NRC regulatory conferences
- Proactively monitor, identify, analyze and mitigate nuclear regulatory compliance risks; and, in coordination with affected business leaders, develop and execute risk mitigation plans
- Oversee the day-to-day implementation of the global Nuclear Ombuds Program, including but not limited to the following
- Assist in the implementation of the company’s compliance policies and procedures for the Residential Servicing Department
- Assist in the implementation of the company’s compliance policies and procedures for all Marketing and Training activities
- Assist in the implementation of the company’s compliance policies and procedures for the compliance with all State laws and regulations
- Manage Freedom Mortgage Corporation’s examinations by State Regulators and Freedom’s responses there to
- Providing advice that protects the Bank’s reputation and mitigates legal risk
- Demonstrates highest professional ethical and behavioral standards, and complies with all applicable Bar Rules and Codes of Professional Responsibility
Education
Palm Beach Atlantic University
2007 - 2011
Bachelor's Degree in Management
Professional Skills
- A strong work ethic, excellent communication skills, sense of humor and an ability to handle multiple projects simultaneously
- Strong time management and organizational skills – able to manage a number of projects and different demands simultaneously
- Strong interpersonal skills and strategic thinking
- Excellent legal, analytical, communication and presentation skills
- Strong interpersonal and exceptional written and verbal communication skills
- Outstanding verbal and written communication skills and advances knowledge of the law
- Develop policies and programs involving priority matters affecting the regulations of drug products
How to write Regulatory Counsel Resume
Regulatory Counsel role is responsible for interpersonal, leadership, security, finance, securities, training, integration, recruiting, litigation, telecommunications.
To write great resume for regulatory counsel job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Counsel Resume
The section contact information is important in your regulatory counsel resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Regulatory Counsel Resume
The section work experience is an essential part of your regulatory counsel resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory counsel responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory counsel position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Counsel resume experience can include:
- Experience advising and consulting operations on licensing matters, including consumer collections, telecommunications, and loan servicing
- Develops policies and programs involving complex and high priority matters affecting the regulations of Biosimilar biological products
- Proven ability to think clearly and succinctly and cogently articulate a negotiating position as well as draft contracts in clear, concise language
- Develop and revise regulations and guidance, advising on compliance with FDA's Good Guidance Practice regulations and other legal/regulatory issues
- Assisting training team and other internal stakeholders as needed with development of training programs
- Benchmarking industry practices pertaining to key legal and regulatory requirements
Education on a Regulatory Counsel Resume
Make sure to make education a priority on your regulatory counsel resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory counsel experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Regulatory Counsel Resume
When listing skills on your regulatory counsel resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical regulatory counsel skills:
- Experience advising and supporting the marketing and sale of medical devices and familiarity with U.S. healthcare laws and regulations
- Combined experience in a law firm and/or in-house setting, with a focus on regulatory matters
- Familiarity and/or experience with DOL regulations, ERISA, or IRS rules relating to conflicts of interests, disclosures, and the fiduciary standard of care
- Excellent understanding of the Company’s business with the ability to develop legal strategies to advance Company goals and objectives
- Proven proficiency in MS Word and legal research tools
- Proven ability to work both collaboratively and independently
List of Typical Experience For a Regulatory Counsel Resume
1
Experience For Senior Regulatory Counsel Resume
- Develop policies, programs involving complex high priority matters affecting the regulations of drug products
- Develop policies and programs involving complex and high priority matters affecting the regulations of drug products
- Experience working with industry groups and interaction with regulators
- Demonstrated commitment to providing the highest quality legal services
- Experience responding to attorney demand letters
- Experience responding to government investigations and audits
- Review and evaluate evidence for legal and administrative action recommendations
- Developing a thorough understanding of and familiarity with the operation of the company’s business, products, markets, facilities and customers
- Supporting special projects, including product development, launch of new funds and investment products, and other investment management-related matters
2
Experience For Litigation & Regulatory Counsel Resume
- Assisting with the development and delivery of specialized training on complex regulatory topics
- Assist in the development of programs involving matters affecting the regulation of the tobacco industry
- Drive and project manage legal projects and conduct training to the regulatory, medical affairs, sales and marketing teams
- ONADE accomplishes its mission by ensuring four critical review standards are met before a drug is approved for marketing
- Reduces expenses in providing internal legal advice
- Leads in complex and sensitive negotiations; considers the long-term consequences and coaches clients towards protecting the Company's interest
3
Experience For Markets Regulatory Counsel Resume
- Anticipates client needs; deals with complex legal issues; delivers difficult messages without jeopardizing client relationships
- Written Communication:Writes human and animal food or import related documents in a clear, concise, organized, and convincing manner for the intended audience
- Ability and willingness to travel, including to our Washington, D.C. office, as needed
- Develop a thorough understanding of and familiarity with the operation of Brightstar’s business, products, markets, partners and customers
- Work with and oversee outside counsel on a variety of legal matters, ensuring that standards for service delivery and cost are controlled efficiently
- Work with client-service and sales groups to respond to client and prospective client inquiries regarding litigation and regulatory inquiries
- Provide technical guidance on procedures and methods involved in implementing new programs, guidance, and regulations
4
Experience For Regulatory Counsel, Gs Resume
- Analyze issues concerning administrative policies and/or manangement theories that required adaption for application to internal program issues and problems
- Conduct analysis of regulatory and policy issues and provide advice to staff in carrying out its regulatory mission
- Draft and comment on proposed legislation on matters pertaining to FDA's jurisdiction
- Interact directly with the company’s issuing banks and third-party distributors on legal and compliance issues
- Ensure that regulations and policies developed in the assigned areas are consistent with the statutory requirements and existing policy
- Drafts or critically review documents embodying policy and program proposals and decision on these products
- Drafts or critically reviews regulatory documents embodying policy and program proposals and decisions on these products
5
Experience For Senior International Telecom & Media Regulatory Counsel Resume
- Conduct research regarding established precedents in order to develop and support legally sufficient regulations, citizens? petition responses, and policies
- Draft and comment on proposed legislation on matters pertaining to FDA?s jurisdiction
- Prevents and/or resolves conflicts with the team; encourages and empowers others
- Assists in the management of expenditures for outside counsel
- Advises lines of business on practices that help minimize legal and litigation risk
- Resolves most situations where conflicts arise between the needs and desires of specific business units and the interests of the company without requiring intervention of more senior lawyers
6
Experience For Product & Regulatory Counsel Resume
- Inspires the confidence of clients by clearly understanding the client's role with the Company and considers the practical business implications of legal advice
- Identifies relevant facts; gathers relevant information from appropriate resources; evaluates the reliability of information obtained
- Knows relevant substantive law; identifies legal issues for business units and formulates relevant legal strategies
- Provides advice in ambiguous situations; identifies and reduces future legal risks; identifies and takes action on future opportunities
- Work with industry groups and colleagues in the U.S. and overseas to advocate BNPP’s position to proposed regulatory change
- Develop a thorough understanding of and familiarity with: Edwards’ business, its people, products, markets, facilities, customers and competitors and use this knowledge in providing guidance and counsel to Edwards clients
7
Experience For Regulatory Counsel Marketing & Training Resume
- Management and direction of Brightstar’s insurance and service contract licensing portfolio, which includes insurance adjuster, insurance agency, service contract, TPA and other licensing and appointments held in the name of Brightstar, its employees and its clients
- Assisting with the research and development of new fund products
- Analyzes new laws and regulations applicable to the Company’s benefit and incentive plans and assisting HR with its compliance strategy
- Obtains advice, performs research and drafts memoranda on legal aspects of the roll-out of new products and the development of new distribution channels
- Conduct legal research to support Airbnb’s new offerings and to help develop a legal strategy for Airbnb’s growth
- Collaborating with Compliance and business personnel on relevant compliance related matters and developing and modifying practices and procedures to conform with legal requirements; Assisting in identifying, developing and implementing control enhancements and risk mitigation strategies
- Providing advice and guidance with respect to issues associated with the distribution, including issues posed by the activities of Morgan Stanley’s limited purpose broker dealer
- Staying abreast of regulator rule interpretations and related enforcement actions to advise the firm on best practices for compliance with relevant regulations and assess areas of risk
8
Experience For Regulatory Counsel, Senior Resume
- Collaborating with internal stakeholders to implement effective, efficient and commercially viable solutions for implementation and ongoing compliance with derivative/financial product regulations
- Preparing content for updates to senior management and other internal stakeholders in regard to swap dealer activities and regular compliance communications to relevant staff
- Responsible for maintaining and keeping up-to-date certain compliance policies owned by ORC, including the swap dealer manuals
- Responsible for advising on and drafting, as applicable, new policies designed to ensure compliance with new or changed regulations
- Represent the firm in relation to internal investigations and regulator examinations, inquiries and other matters
9
Experience For Regulatory Counsel / Paralegal Resume
- Oversee aspects of litigation related matters (respond to subpoenas, conduct document collections, review, and productions, prepare witnesses for depositions, review pleadings and briefs, etc.)
- Review and evaluate litigation, litigation opportunities, and litigation risk in various domestic and international jurisdictions
- Respond to global regulatory requests and audits, including assisting with regulatory inquiries and exams such as SEC, FINRA, DOL, CFTC, NFA, IRS, FCA, and ASIC
- Perform additional responsibilities in the Legal Department as requested
- Practice (with domestic and international securities or financial services litigation experience) in a top-tier law firm, with a regulator or in-house corporate or funds attorney
- Advising on a range of compliance and regulatory issues related to the XL Catlin regulated (insurance and reinsurance) and non-regulated entities based in Switzerland
- Liaison with FINMA: provide the regulator with ongoing information about Group projects affecting the Swiss regulated entities
- Keep register of outsourcing agreements
- Registration and renewal of licenses abroad of our Swiss admitted reinsurer carrier (particularly in LATAM)
10
Experience For Senior Regulatory Counsel, GS Resume
- Keep register of licenses abroad and monitor deadlines
- Liaise with Legal and Finance Team for any Tied assets issues and other legal , compliance and regulatory issues
- Liaise with external law firms in Switzerland and abroad for all compliance and regulatory matters
- Liaise with Actuarial, Finance, Risk Management on ORSA
- Attend quarterly the Risk Monitoring Committees (RMC) and the Boards of the regulated entities and provide compliance and regulatory risk reports to the RMC and the Boards
- Provide local compliance trainings to new starters and Swiss staff (insurance and reinsurance)
List of Typical Skills For a Regulatory Counsel Resume
1
Skills For Senior Regulatory Counsel Resume
- Developing policies and programs involving complex and high priority matters affecting the regulation of drug products
- Experience in a law firm and/or corporate legal/compliance department
- High flexible and adaptable; ability to shift focus and priorities easily and quickly
- Experience functioning as an attorney in a law firm or as in-house legal counsel
- Develops regulations, policies, and programs involving complex and high priority matters affecting the regulation of FDA products
- Researching regulatory issues and providing recommedations to revise existing or to create new policies and regulations
- Leading change:ability to thrive and quickly adapt to change, leading others through change in a dynamic, fast-paced industry and work environment
- Monitoring compliance and regulatory developments and trends affecting products and operations
2
Skills For Litigation & Regulatory Counsel Resume
- Participating in industry-wide and internal calls/meetings to monitor regulatory activity and industry practices and compliance strategies
- Assisting Chief Compliance Officers in support of the production of the swap dealer and futures commission merchant Annual Reports to the CFTC
- Advising the swap dealer and FCM risk management committees on relevant regulations
- Filing business plan changes applications to FINMA
- Review advertising and marketing materials to ensure compliance with legal requirements, including real estate licensing laws
- Retain and supervise outside counsel on civil litigation and regulatory matters, including reviewing and evaluating outside counsel fees
3
Skills For Markets Regulatory Counsel Resume
- Provide training to the company, including licensing and regulatory issues
- Strategic thinking:capable of providing clear, balanced advice/counsel on a broad range of regulatory laws and regulations
- Collaborating and influencing:effectively builds strong relationships and partnerships within and outside of the company; ability to effectively navigate within a matrixed corporate structure
- Communicate effectively at all levels of the organization with an open, honest and direct communication style that establishes an empathetic and effective relationship with front-line, mid-level, and executive personnel
- Support the US Head of Regulatory Policy, keeping them informed and escalating issues where appropriate
- Draft, negotiate and review legal documents including leases, LLC operating agreements and vacation rental management agreements
- Research legal issues and draft memos summarizing the research; draft internal policies regarding same
- Research legal issues and draft memos summarizing the research; draft internal policies regarding the same
4
Skills For Regulatory Counsel, Gs Resume
- Expertise at drafting legal memos and related advice documents, and policies and training documents
- Provide guidance and/or training to regulatory specialists and other professionals within FDA on matters relating to his/her expertise
- Reviews petitions raising issues that effect a segment of the regulated industry as well as those that pertain to the marketing status of individual products
- Manage the company’s litigation, including navigating the company through regulatory inquiries, investigations, etc
- Develop policies and programs involving matters affecting the regulation of tobacco products
- Review and advise on pending and developing competition regulation and developments
- Develops policies and programs involving matters affecting the regulation of the tobacco industry
- Report as needed to senior management within Legal and the relevant business line with respect to ongoing litigation and regulatory matters
- Facilitate the development, setting and delivery of the framework for financial markets regulatory policy applicable to Barclays across the US
5
Skills For Senior International Telecom & Media Regulatory Counsel Resume
- Sound understanding of Swiss compliance and regulatory environment
- Reports to: Senior Counsel or Managing Senior Counsel
- Work without supervision, while exercising sound, independent judgment
- Aptitude to work well with larger team on seeking efficiencies for legal support
- Responsible for being knowledgeable of relevant regulations and Macquarie’s related policies
- Supervises staff functions to oversee planning, direction and execution of program segments
- Evaluates training and budget recommendations for the Division
- Can do attitude who is willing to take on any matter or project whether large, small, complex, simple, and/or novel
6
Skills For Product & Regulatory Counsel Resume
- In addition, ONADE considers the impact of an animal drug on the environment during the review process
- The Vacancy ID Number (VIN) is 1941838
- Fax your documents to 1-478-757-3144 with the coversheet on top
- Work in conjunction with the Bank’s New York office to manage civil litigation and regulatory matters
- Handle responses to regulatory requests for information, complex subpoenas, non-party subpoenas issued in connection with civil litigations, and other non-party legal process seeking production of documents or testimony
- Manage the collection and review of materials for production in civil litigations and regulatory matters, including review for responsiveness, privilege and confidentiality (including the management of outside resources as necessary)
7
Skills For Regulatory Counsel Marketing & Training Resume
- Prepare, or assist in preparing, witnesses, defend depositions, and attend hearings relating to testimony sought by non-party subpoenas and other legal process
- Negotiate regulatory and civil litigation settlements and the scope of subpoenas and document requests
- Perform other tasks attendant to the oversight of litigation and regulatory enforcement matters (such as entry and updating of matters in litigation management system, reporting to management, auditors, insurance carriers, etc.)
- Ensure data quality and accuracy is maintained for matter management and operational risk systems
- Work on special projects within Legal, and with other infrastructure groups or DB businesses
- Represent Barclays before Congress, particularly in the context of issues related to the policy areas listed above
- Swiss qualified Lawyer (Bar exam)
8
Skills For Regulatory Counsel, Senior Resume
- Postgraduate education such as an LL.M. is of additional value
- Several years of international legal practice, acquired in a reputable law firm and/or as an in-house counsel preferably in the insurance industry
- Advise and manage the purchase and maintenance of insurance products related to our operations
- Lead responses to audits and investigations
- Contribute to the overall strategy development of our legal team and Vacasa as a whole
- Manage one or more employees as needed
- Proficiency with computer software programs such as Word, Excel and Google Apps
- Lead responses to regulatory audits and investigations
- Licensed to practice in a US jurisdiction … active bar membership
9
Skills For Regulatory Counsel / Paralegal Resume
- Licensed to practice in a US jurisdiction with a active bar membership
- Appropriate legal qualification and admission to practice law in relevant jurisdiction
- Experience providing legal/regulatory advice in the investment management industry and a strong understanding of the institutional asset management business
- Knowledge of the Federal Advisory Act, the Food, Drug, and Cosmetic Act, and/or the Ethics in Government Act, laws, legislation, policies and guidelines
- Provide solutions to issues related to Advisory Committee operations
- Work collaboratively with others at all levels of the Company, both within and outside of the Legal Team
- Work with, and maintain, highly confidential information
- In-depth knowledge of healthcare reimbursement regulations and laws, regulations and federal health care program requirements
- Carry out/lead regulatory policy engagement with key financial market regulatory agencies (at all levels of seniority) to further the Group’s strategic priorities in the context of markets regulation and seek to establish relationships of trust in this context
10
Skills For Senior Regulatory Counsel, GS Resume
- Facilitating the formulation of all aspects of financial markets regulatory policy affecting Barclays’ position and response to changes in regulation across the areas the Barclays Group operates in across the US
- Ensuring regular updates of the regulatory policy agenda relevant to the US are provided to regional management and key Legal and other stakeholders; working very closely in partnership with colleagues notably in impacted business areas, Legal, Market Structure, Compliance, Government Relations and Risk
- Acting as principal point of contact for internal and external stakeholders in relation to financial markets regulatory policy, including with relevant regulators and other government officials
- Representing the firm in relation to US regulatory policy and participating in and working with relevant industry bodies and groups
- Leading the Financial Services Regulatory Legal Team’s input into key internal projects impacting the region
- Managing and supervising the input of external advisers in the regulatory policy space
- Contributing to Financial Services Regulatory Legal Team reporting, know-how and other policy development work; and
List of Typical Responsibilities For a Regulatory Counsel Resume
1
Responsibilities For Senior Regulatory Counsel Resume
- Regulatory experience in the health care or medical device industry
- Review petitions raising issues that effect a segment of the regulated industry as well as those that pertain to the marketing status of individual products
- Review regulatory documents embodying policy and program proposals
- Sanctions (participation to sanctions group regular calls)
- Serve as a recognized government-wide regulatory expert and authority in matters and is frequently called on to advise others concerning FDA statutes and regulations
- Resolve a broad range of issues concerning the application of any FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government
- Develop and participate in the implementation of policies and programs involving matters affecting the regulation of FDA Advisory Committees
- Draft or review proposals for new regulations and policy statements involving assigned area of regulatory expertise
- Make presentations before the regulated industry, clinical investigators, and the medical/scientific community on the applicable regulations and policies
2
Responsibilities For Litigation & Regulatory Counsel Resume
- Review potentially disqualifying financial conflicts of interests and other legal matters for special Government employees and regular Government employees in relation to the relevant statues and regulations to determine an employee's eligibility for participation at an advisory committee meeting
- Prepare high-level regulatory decision documents for approval or disapproval of appropriate actions to upper management
- Inform management and staff on new or revised regulations, internal policies and procedures, and trends in the pharmaceutical and health care industry
- Draft/review proposals for new regulations and policy statements
- Identifies complex program issues or problems in programs of small scope. Makes recommendations for and coordinates resolutions and improvements
- Drafts and comments on proposed legislation on matters under FDA's jurisdiction
- Maintains current knowledge of scientific subjects pertaining to the regulatory area and applies specialized technical knowledge to recommend far reaching improvements to regulatory review process
3
Responsibilities For Markets Regulatory Counsel Resume
- Provides advice on the interpretations of the laws, regulations, and policies applicable to the Center of FDA
- Writes and establishes policies and procedures that ensure the sufficiency and procedural adequacy of policy statements and policy initiatives
- Ensure that regulations and policies developed in the assigned areas are consistent with the statutory requirements and existing policy, that their need is justified, and that they are adequately supported by appropriate analysis including adequate scientific and medical analysis when required
- Advise other offices in the Center on procedures and methods for implementing new regulations and revising existing regulations and on the sufficiency and procedural adequacy of proposed policy statements and policy initiatives
- Ensure that regulations and policies developed in the assigned areas are consistent with the statutory requirements and existing policy, that heir need is justified, and that they are adequately supported by appropriate analysis including adequate scientific and medical analysis when required
4
Responsibilities For Regulatory Counsel, Gs Resume
- Reviews proposals and makes recommendations for new guidance documents that affect regulatory activities, utilizing knowledge of the Tobacco Control Act, The Federal Food, Drug and Cosmetic Act, and related statutes enforced by the FDA
- Participates in working groups of scientific, regulatory, and legal experts to develop new or revised regulations
- Draft replies to correspondence from the regulated community and other interested persons on issues that effect one or more portions
- Provides advice on the interpretations of the laws, regulations, and policies applicable to the Center and FDA
- Keeps abreast of regulatory and legislative changes from initial analysis through final review or implementation to ensure timely completion and compliance with designated regulatory guidelines
- Drafts and comments on proposed legislation on matters under CDRH's jurisdiction
5
Responsibilities For Senior International Telecom & Media Regulatory Counsel Resume
- Utilize resources such as Westlaw, LexisNexis, MediRegs, the US Code, the Code of Federal Regulations, the Federal Regulations, and others, to conduct research regarding established precedents in order to develop and support legally sufficient regulations, citizens' petition responses, and policies
- Participate on working groups of scientific, regulatory and legal experts to develop new or revised regulations and draft the resulting notices of proposed rulemaking
- Prepare replies to correspondence from the regulated community, Congress, and other interested persons on issues that are industry-wide in scope
- Consult with appropriate scientific experts and drafts responses to citizen petitions, petitions for stay of action, and/or petitions for reconsideration
- Advise staff in the office of Chief Counsel and other offices in the Office of Commissioner on matters related to the Regulatory Counsel's responsibilities
- Manage the company’s government affairs
- Interact directly with federal and state regulators on matters related to the company’s business
- Manage the implementation of necessary controls across the organization driven by legal or regulatory requirements/guidance
6
Responsibilities For Product & Regulatory Counsel Resume
- Provide legal support in development of innovative new financial products
- Resolve a broad range of issues concerning the application of any of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government
- Serve as a recognized government-wide regulatory expert in matters related to his or her area of responsibility and is frequently called on to advise others concerning FDA statutes and regulations
- Make presentations at conferences and professional meetings in the U.S. and overseas before the regulated industry, clinical investigators, and the medical/scientific community on the applicable regulations and policies
- Draft or review proposals for new regulations and policy statements involving his or her area of regulatory expertise
7
Responsibilities For Regulatory Counsel Marketing & Training Resume
- Prepare replies to correspondence from the regulated community and other interested persons on issues that are industry-wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy
- Conduct legal research to establish the legal basis for drafting proposed regulations, guidance documents, and other regulatory documents
- Provide authoritative advice and assessments of the impact and actual and proposed Administration or Congressional actions on the programs, functions, and activities of the Center
- Develop and draft a wide range of regulatory and policy documents, often leading working groups within the Center and participating on behalf of Center of Tobacco Products on Agency-wide working groups or teams
- Assist in the development of programs involving matters affecting the regulations of the tobacco industry
8
Responsibilities For Regulatory Counsel, Senior Resume
- Review regulatory documents embodying policy and program proposals and decisions on these products
- Make presentations at conferences and professional meetings before stakeholders on the applicable regulations and policies
- Assist in drafting replies to correspondence from the regulated community and other interested persons on issues that affect one or more portions of the regulated industry
- Assist in developing presentations at conferences and professional meetings before the regulated industry, clinical investigators, and the medical/scientific community on the applicable regulations and policies
- Assist in drafting replies to correspondence from the regulated community and other interested persons on issues that effect one or more portions of the regulated industry
9
Responsibilities For Regulatory Counsel / Paralegal Resume
- Review petitions raising issues that affect a segment of the regulated industry as well as those that pertain to the marketing status of individual products
- Directs employees to review advisory committee materials, documents associated with biologics approvals and other relevant documents for proactive disclosure and posting on FDAs web site
- Performs individual performance reviews and provides ratings to employees at the end of the performance period
- Provides direction and support to the Office of Legislation to responds to requests to the agency
- Communicates work requirements to employees and internal stakeholders
- Reviews attendance documentation and other administrative correspondence for employees
- Evaluates performance and provides administrative guidance to employees
10
Responsibilities For Senior Regulatory Counsel, GS Resume
- Understands the Employee Relations process
- Oversees the process regarding proactive disclosure; and posting on FDAs web site in accordance with the Freedom of Information Act and the Federal Food, Drug and Cosmetic Act
- OD is also responsible for CVM's Freedom of Information Act activities, stakeholder outreach and engagement, customer service through the Ombudsman, and international relations
- In addition, OD oversees information management operations involving website content and 508 compliance requirements
- OD provides individual and team coaching services and internal organizational change advice in support of CVM's operation as a high performance organization
- Develop policies and programs and drafts/reviews regulations and policy statements involving complex matters affecting the regulation of animal drugs, foods and food additives
- Prepare communications to the regulated community and other stakeholders on public health matters that require precedent setting interpretations of FDA policy
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