The Regulatory Affairs Manager (called a Product Development Champion [PDC] at Facet) is focused on helping emerging companies advance their drug, biologic, device, and combination products through any or all stages of regulated development. This involves helping some companies determine what is needed to get their product from the bench into humans. For others, the path to success involves executing on an aggressive clinical and regulatory plan to achieve registration with FDA under tight budget constraints.
To be successful, the PDC will formulate, lead, and implement innovative regulatory strategies based on client input (stated goals, corporate objectives, and risk tolerance), their experience with the regulatory, medical and commercial environment, and through strong teamwork with Facet colleagues and partners. The PDC is accountable for direct interactions with FDA and timely submissions to health authorities. Success requires strong interpersonal skills (e.g., good negotiation, conflict management), a willingness to bird-dog information and formulate “outside the box” recommendations (often with limited input), and an ability to analyze complex issues and distill them into simple, actionable strategies.
At Facet, the PDC:
- Develops and leads US regulatory strategies and contingency plans for the development and registration of drugs, biologics, vaccines, medical devices, cellular, protein, gene therapy, and combination products
- Serves as the primary liaison between Facet clients and FDA (US Agent)
- Champions FDA meeting activities, including preparation of meeting materials, meeting preparation, and meeting attendance
- Actively participates in the preparation of regulatory submission content. Works with cross-functional teams and partner organizations to define contributions to submissions
- Serves as the clinical and/or CMC regulatory content expert on project teams and within Facet
- Authors and/or reviews regulatory documents for regulatory submission.
- Maintains knowledge of global competitive landscape, regulatory environment, regulations and guidances
- Actively participates in service to the industry (e.g., industry memberships, conference presentations, publications)