Remote - Candidates must be located in the United States - Ideally Southern California
The Sr. Director/Director of CMC Regulatory Affairs will be responsible for developing, leading and executing CMC regulatory strategies and activities for the organization, including the preparation and filing of BLA submissions. This position is a hands-on role, providing both strategic and operational activities to support regulatory needs for rare disease studies. This role will report to the global Head of Regulatory.
Responsibilities:
Lead a team of stakeholders to develop/implement effective CMC regulatory strategies for submissions (e.g. BLA/MAA) and identify regulatory risk
Ensure oversight of multiple programs and drive regulatory CMC strategy successfully
Lead and be responsible for module 3 of the regulatory submissions
Provide strategic advice to manufacturing and quality teams on complex technical and regulatory CMC topics
Evaluate proposed manufacturing and quality changes
Review documents for submission-readiness, to ensure that all submissions conform to relevant guidelines
Manage interactions and maintain excellent relationships with regulatory authorities
Represent the company in front of FDA and EMA and or local regulatory authorities and be able to defend the company's strategy
Education and Experience:
MS/PhD degree in a scientific/engineering discipline
Experience representing the teams in front of FDA/EMA
10+ years of experience in regulatory CMC at global level, including biological medicinal products, including writing and compiling module 3
Strong knowledge of current US, EU, and rest of the world regulations
Strong experience with CTD format and content regulatory filings
Demonstrated ability to deliver high quality regulatory CMC documents, and influence of regulatory authorities