The Regulatory Affairs Manager (called a Product Development Champion at Facet) is focused on helping emerging companies advance their drug, biologic, device, and combination products through any or all stages of regulated development. For some companies, this involves helping educate them on what is needed to get their product from the bench into humans whereas 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 Product Development Champion is required to 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 Product Development Champion 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.
The Product Development Champion will:
- Lead US and/or global regulatory strategy and submission teams on assigned projects.
- Serve as the clinical and/or CMC regulatory expert on project teams and within Facet.
- Develop global and/or regional regulatory strategies and contingencies for investigational, new or modified products.
- Serve as the primary liaison for FDA on assigned projects (US Agent). Interface and coordinate with the regulatory agencies (i.e. FDA) on submissions, approvals or other topics.
- Lead the preparation of submissions, which may include initial and maintenance IND, IMPD, NDA/MAA/BLA, CTA, DMF, IDE, 510(k), PMA or other regulatory applications. Work with cross-functional teams and partner organizations to define contributions to submissions.
- Author and/or review submissions and other regulatory documents.
- Coordinate regulatory agency meeting activities, including preparing meeting materials and meeting attendance.
- Represent Facet on various cross-functional teams, including project teams, clinical development teams, manufacturing teams, etc.
- Maintain project budgets.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
- Contribute to the development and maintenance of Facet and departmental working practices and procedures.
- Assist with the preparation of sales materials and client proposals.
- Actively participate in service to the industry (e.g., industry memberships, conference presentations, publications).
- Assist in strategic discussions regarding services and software development activities, as appropriate.
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