ul>JD from an ABA-accredited law school and admission in good standing to at least one U.S. jurisdiction; Minimum of 12 years of post-JD experience advising on legal matters in the life sciences industry, including significant FDA regulatory law experience gained through law firm practice focused on FDA and regulatory matters or relevant government service, such as at the FDA; Deep expertise in U.S. regulatory frameworks, with working knowledge of EMA processes preferred; Demonstrated experience advising on complex regulatory strategy and novel modalities; Demonstrated experience advising cross-functional teams on clinical research, drug development, regulatory submissions, GCP, and related compliance frameworks, including regulatory exclusivities, orphan drug designations, as well as privacy, fraud and abuse, and product liability laws; Strategic thinker who translates complex regulations into pragmatic, risk-based business guidance; Strong executive presence and proven influence with senior stakeholders in a matrixed organization; Exceptional judgment, collaboration, and interpersonal communication skills; Maintains an independent, objective perspective while building strong partnerships with colleagues; Thrives in ambiguous, high‑stakes environments; Works independently, manages multiple matters, and delivers high-quality work under tight timelines; High integrity, forward-looking perspective, and a solution-oriented approach; Advanced contracting and redlining skills, with strong attention to detail; Ability to manage outside counsel effectively and efficiently while adhering to budget expectations. This role provides expert counsel to cross-functional partners across Regulatory Affairs, Public Policy & Government Relations, Therapeutic Area leadership in Cardiometabolic Disease and Neuroscience (and future therapeutic areas), Safety & Risk Management, Quality Assurance, Data Sciences, and Research & Early Development, empowering scientific innovation while managing regulatory and legal risk.