Senior Regulatory Legal Counsel, Director (Hybrid)

Job Description

General Summary:

The primary purpose of the Senior Regulatory Legal Counsel is to independently and proactively provide solutions-oriented legal advice and support to a broad array of internal clients from the following functions: Regulatory Strategy, Labeling & CMC, Regulatory Policy, Regulatory Intelligence, Federal Government Affairs, Safety, and Quality. The position reports to the Assistant General Counsel of Regulatory and Development Legal.

Key Duties and Responsibilities:

• Leverages deep domain expertise in regulatory law to provide legal advice, education, and proactive counsel regarding the following:

  • Clinical development of investigational compounds (including design of studies to support regulatory approval), regulatory strategy for new products and line extensions, Hatch Waxman issues and life cycle management, and design and use of real-world studies to support regulatory submissions

  • Interactions with regulators, including crafting legal arguments for inclusion in regulatory submissions and helping teams prepare for formal meetings with FDA and advisory committee meetings, as well as Health Canada

  • FDA's expedited programs for serious conditions, such as accelerated approval, fast track designation, breakthrough designation, priority review, as well as on exclusivity issues

• Proactively identifies and addresses regulatory law issues, fostering trusted relationships with client groups and serving as a standing- or ad hoc member of business or leadership teams

• Provides legal regulatory advice on U.S. pharmacovigilance compliance and drug safety matters, including global regulatory reporting requirements, internal monitoring and auditing, corrective action plans, dear healthcare provider letters, and regulatory inspections, investigations and enforcement actions involving pharmacovigilance

• Advises on GxP matters from a global legal perspective in support of manufacturing and distribution activities, namely good manufacturing and distribution practices. Responsibilities include counseling on deviations, internal monitoring and audit activities, corrective action plans, global reporting requirements, and GMP-related inspections, investigations and enforcement actions.

• Monitors drug development industry and policy trends and proactively advises on strategies to shape the landscape and support the success of Vertex's drug development programs in the context of an evolving and complex external regulatory environment

• Provides legal regulatory advice on proposed legislation, regulations and FDA guidance to inform advocacy efforts. Helps to draft responses to proposed laws and regulations, FDA guidance documents, and industry group policy positions.

• Conceptualizes, designs, and deploys internal legal learnings-raising awareness and organizational knowledge of leading/emerging best practices and solutions in regulatory law

• Additionally, the Senior Regulatory Legal Counsel:

  • Teams with and provides regulatory law support to commercial attorneys on advertising and promotion issues

  • Provides regulatory law support for transactions, including conducting regulatory due diligence, negotiating key regulatory terms, and supporting post-transaction integration activities

  • Provides agile resourcing support in areas such as R&D law

  • Contributes to the evolution of regulatory law legal service delivery, focusing on areas of highest strategic value add and risk mitigation, while continuously improving and seeking alternate solutions for how tactical legal support is enabled

  • Serves as a member of various cross-functional teams

  • Drives and contributes to various department and cross-functional governance and process improvement projects

  • Participates in various other Legal & Compliance Department projects and initiatives

Knowledge and Skills:

• Legal Expert:

  • Advanced depth of knowledge of the laws, regulations and industry standards applicable to the area of responsibility

  • Specific expertise required in statutes, regulations and guidance concerning: GxP, drug development, regulatory submission standards, expedited programs for serious conditions, Hatch-Waxman, Orphan Drug Act, DQSA, and fraud and abuse

  • Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products

  • Strong analytical and complex problem-solving skills. Sound judgement.

  • Capacity to simultaneously handle a variety of complex legal matters with minimal guidance

• Business-Minded Leader:

  • Advanced understanding of operations, structures/functions, stakeholders, and objectives, as well as the industry and environment operated in and the way in which the Department contributes to success. This includes the ability to leverage that understanding to provide relevant and actionable counsel.

  • Significant understanding of business drivers, ability to align areas of responsibility to the business strategies

  • Ability to take ownership of issues with greatest impact to the business

• Trustworthy Advisor:
  • Advanced ability to provide a sound recommendation or solution to appropriately assess risk by leveraging one's expertise, and to deliver ethical, practical, trustworthy, and solutions-oriented advice and decisions
  • Ability to create buy-in and trust
  • Ability to constructively counsel and influence clients in making the optimal decisions

• Influential Communicator:
  • Advanced skill to clearly and succinctly convey, both orally and in writing, relevant information that is tailored to distinct audiences, and influence others either to adopt a specific viewpoint, take a specific course of action, or incorporate the information provided
  • Ability to work cross-functionally and independently
  • Ability to articulate legal concepts, and their implications efficiently and effectively
    

Education and Experience:

• JD or LLM from an ABA accredited law school and member of a state bar

• 8-10+ years' regulatory legal experience with global regulatory requirements in the pharmaceutical or biotechnology industry, whether in-house, at a law firm, or at a regulatory agency-or in combination

• Experience advising and supporting senior level stakeholders

Flex Designation:

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com