Regulatory Strategy Associate Director

Job Summary The Regulatory Strategy Associate Director will oversee the development of regional or global regulatory strategy for development programs or marketed products, acting as a global or regional regulatory lead within the Vertex portfolio. Key Responsibilities Lead development and implementation of global regulatory strategy for assigned projects across development and commercial stages. Develop and lead regional regulatory strategy that informs the global strategy for specific projects. Lead regulatory communications and interactions with health authorities. Advise teams on regulatory requirements for development and approval pathways, including expedited pathways. Oversee preparation, submission, and approval of regulatory applications. Provide strategic and technical regulatory input for key product development or registration documents. Ensure regulatory submissions comply with current regulations and guidance. Review and evaluate regulatory intelligence and guidance to continuously inform strategy. Advise cross‑functional teams and senior management on regulatory risks, considerations, and strategies. Act as an advisor and coach, mentoring team members. Knowledge and Skills Specialized knowledge of global and regional regulatory affairs frameworks and guidelines. Understanding of requirements and processes to maintain a product on the market, including labeling, reporting, and surveillance. Comprehensive understanding of drug development concepts (clinical trial design, statistics, clinical pharmacology). Ability to assess complex scientific information, regulatory precedent, and competitive intelligence to make recommendations. Strong problem‑solving skills. Proficiency with emerging technologies, including AI‑driven tools, and a continuous learning mindset. Strong written and verbal communication skills, tailored to multiple audiences. Ability to lead and work within a team environment. Prior experience with major health authority submissions and interactions is required. Education and Experience Bachelor's degree in biology, chemistry, or a related discipline, combined with typically 8 years of relevant pharmaceutical or biotech industry experience in regulatory affairs, or the equivalent combination of education and experience. Pay Range and Benefits Pay Range: $168,000 - $252,000. Eligible for an annual bonus, equity awards, and potential overtime pay in accordance with federal and state requirements. Benefits include medical, dental, vision, paid time off, student loan repayment assistance, commuting subsidy, charitable donations matching, and 401(k). Flexibility: Hybrid‑eligible (up to two remote days per week) or on‑site work five days per week. EEO Statement 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. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)