The Director/Senior Director, Regulatory Affairs will be responsible for developing, implementing, and advising on the overall regulatory strategy for development programs, assuring that regulatory documents are in compliance with health authority regulations and interacting with US and international health authorities. The incumbent will lead submission and approval of IND applications for clinical trials, serve as decision maker on submission readiness, and represent the company at FDA and in other external forums. This individual will identify and recommend the most effective path to regulatory approval to bring the company’s products to market in a cost-effective, compliant manner.
- Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent.
- Provide regulatory due diligence and regulatory advice for potential new product opportunities.
- Provide guidance on regulatory mechanisms to optimize product development.
- Responsible for the coordination, preparation and review of regulatory submissions (US and EU/ROW)
- Ensure compliance with existing regulatory applications (e.g., IND maintenance including submission of Safety Reports, investigator documentation and Annual Reports)
- Development and preparation of successful regulatory strategies and ability to write and defend such strategies.
- Ensure that all projects have a clearly defined regulatory pathway and milestones leading to successful filings and approvals
- Oversee the development and management of defining key regulatory timelines and regulatory critical path activities
- Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
- Communicate effectively with senior management personnel (and external partners, where appropriate)
- Develop and manage regulatory budgets and resources
- Contribute to due diligence efforts
- BS or BA in a scientific discipline and/or equivalent experience; Advanced degree strongly desired with 10+ years in industry and at least 8+ years in Regulatory Affairs
- Experience in preparing regulatory strategies (e.g., regulatory development plans), highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
- Previous experience in a senior regulatory role, including interactions with regulatory agencies (as lead regulatory representative)
- In-depth understanding of regulations and guidelines governing all phases of drug development (for both drugs and biologics)
- Excellent verbal and written communication skills including presentation skills
- Prior experience with the development of oncology products is desired