Job Description
General Summary:
The Global Regulatory Senior Legal Counsel provides proactive, solutions-oriented legal counsel to business functions across Regulatory Strategy, Global Labeling and CMC, Regulatory Policy, Regulatory Intelligence, Government Affairs, Safety, Quality, Clinical Development, and Manufacturing. The role supports multiple therapeutic areas, with a particular focus on Endocrinology. This position reports to the Assistant General Counsel, Regulatory and Development Legal.
Key Duties and Responsibilities:
Advise on global regulatory matters related to the clinical development of investigational compounds, including study design to support regulatory approval, strategies for new products and line extensions, lifecycle management, and the use of real-world studies in regulatory submissions.
Provide regulatory legal support across multiple therapeutic areas, with a particular focus on the global development, launch, labeling, and lifecycle strategies for Endocrinology programs and assets.
Counsel teams on the interpretation and application of international regulatory frameworks and interactions with health authorities, including the U.S. Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and health authorities in Latin America.
Support the development of legal arguments for regulatory submissions and preparation for formal health authority and advisory committee meetings.
Proactively identify and address regulatory legal issues and build trusted relationships with business partners.
Advise on global pharmacovigilance compliance and drug safety matters, including reporting requirements, internal monitoring and audits, corrective action plans, and related inspections, investigations, and enforcement actions.
Advise on global GxP matters involving clinical development, manufacturing, distribution, and quality, including deviations, monitoring and audits, corrective action plans, reporting requirements, and related inspections, investigations, and enforcement actions.
Monitor drug development, policy, and regulatory trends, and recommend strategies that support Vertex’s development programs in an evolving global regulatory environment.
Advise on proposed legislation, regulations, and health authority guidance to inform advocacy efforts, including responses to proposed requirements and industry group policy positions.
Develop and deliver internal legal training on emerging regulatory law issues and best practices.
Lead and contribute to departmental and cross-functional governance and process improvement projects.
Participate in other Legal & Compliance Department projects and initiatives.
Knowledge and Skills:
Expert knowledge of laws, regulations, guidance, and industry standards relevant to the role, including those governing GxP, drug development, regulatory submissions, and expedited programs for serious conditions.
Deep knowledge of international regulatory frameworks affecting drug development, labeling, pharmacovigilance, quality, manufacturing, and product lifecycle management, including requirements in the U.S., EU, UK, Canada, and Latin America.
Strong understanding of business drivers and the ability to translate legal analysis into practical advice.
Excellent analytical skills, sound judgment, and the ability to solve complex problems.
Exceptional communication and influencing skills, including the ability to advise senior leaders and help teams take appropriate action.
Ability to work independently and cross-functionally in a fast-paced, dynamic environment.
Ability to drive strategic action and build trust and buy-in across teams.
Education and Experience:
JD or LLM from an ABA-accredited law school and membership in good standing in a state bar.
At least 7+ years of regulatory legal experience in the pharmaceutical or biotechnology industry, gained in-house, at a law firm, at a regulatory…