Senior Director, Regulatory Strategy

Location: London, United Kingdom

Key Duties and Responsibilities

• Leads the development of international regulatory strategy for an assigned therapeutic area, which may include multiple and/or complex projects at different stages of development (from first‑in‑human to post‑marketing application stage) outlined in Global Regulatory Strategy Documents including regulatory submission documents and Health Authority communications.
• Represents GRA on core development teams, project teams, and collaborates with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy, as required.
• Provides advanced regulatory solutions and guidance to cross‑functional teams, advising senior management on status of global Regulatory Affairs strategies and tactics.
• Leads the development and management of project plans and timelines and assigns and manages resources effectively to ensure all projects are appropriately prioritized and key goals are met on time.
• Influences regulatory environment through active participation in conferences and industry/agency regulatory meetings, committees, and trade associations; remains up to date on changing regulations, policy and intelligence.
• Works with cross‑department teams (e.g., submission and launch teams) to achieve corporate business and department goals and objectives.
• Leads continuous improvement efforts on existing department processes and strategies, including developing SOPs.
• Leads and coaches the GRA functional teams; may have financial accountabilities and human resource responsibilities for assigned staff.
• Exhibits ownership and accountability for all project and internal assignments and exemplifies Vertex’s core values.

Knowledge and Skills

• Recent direct experience of regulatory submissions and maintenance of approvals across multiple therapeutic areas and product modalities, and leading direct interactions with stakeholders including consultants, partners, EMA, and national authorities.
• Extensive experience defining and executing international regulatory strategy, leading policy discussions focused on Europe.
• Ability to apply regulatory knowledge with a broad global and cross‑functional mindset.
• Excellent communication skills, influencing decisions at all levels, with strong oral/written presentation skills.
• Effective cross‑functional team leadership in a matrix environment.
• Technical expertise in regulatory affairs science; deep knowledge of regulatory frameworks and guidance for pharmaceutical development.
• Empowers team members through delegation and decision‑making.
• Fluent written and spoken English.

Education and Experience

• Bachelor’s degree in life sciences or related discipline required; Master’s or Ph.D. preferred.
• Significant relevant pharmaceutical or biotech industry experience within regulatory affairs and extensive supervisory/management experience, or equivalent combination of education and experience.

Flex Designation Hybrid‑Eligible or On‑Site Eligible; choose Hybrid (up to two remote days per week) or On‑Site (five days per week on‑site).

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.