Senior Director, Global Regulatory Strategy Lead – FDA Regulatory SME
Job Description:
- Responsible for oversight of complex product development within and across Therapeutic Areas
- Provides FDA-specific subject matter expertise at the intersection of FDA regulations, guidances, policy, and product development strategy
- Develops and implements global regulatory strategies to secure and maintain market approval
- Ensures strategic messaging in US regulatory dossiers
- Reviews regulatory documentation for compounds through all phases of development, including post-approval
- Provides consultation and direction on compliance with US regulatory requirements
- Recommends acceleration strategies
- Provides training and advice to RA colleagues on FDA regulatory policy interpretation
- Leverages deep FDA regulatory expertise to assess programs across therapeutic areas
- Responsible for oversight of complex product development and project management
- Communicates to the regulatory team and cross-functionally to carry out objectives established by executive management
Requirements:
- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
- minimum 15 years Regulatory, R&D, or equivalent industry-related experience
- 10+ years of experience at the FDA with increasing responsibilities
- Leadership experience working in a complex and matrixed environment
- Experience bringing pharmaceutical products through development review and approval
- Broad experience contributing to enterprise management of a portfolio of products
- Experience developing and implementing successful global regulatory strategies
- Experience interfacing with FDA and other government regulatory agencies
- Strong verbal and written communicator with strong negotiation skills and strategic thinking
- Strong business acumen and the ability to work under pressure
- Extensive experience interfacing with multiple regional government regulatory agencies preferred.
- Clinical foundation preferred with strong business acumen
- Experience in multiple MOAs
Benefits:
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k) to eligible employees
- participate in our long-term incentive programs
