Our Cambridge, MA small molecule client is growing and looking to add an Associate Director, CMC Regulatory Affairs to support late phase clinical assets (role can work remote)! This role will operate in a high visibility role, be responsible for developing and coordinating regulatory strategies, leading NDA/MAA preparation and submission to regulatory agencies and lead a small team. In this position, they will partner with the Clinical, Medical, Program Management and Alliance Management groups to move this work forward. Other responsibilities include but not limited to:
- Design and support implementation of well-informed global regulatory strategies
- Represent Regulatory Affairs on lead, phase III project sub-teams and provide regulatory guidance (e.g., protocol reviews, report reviews, development plans)
- Support and lead in the preparation of meetings with Regulatory Health Authorities (e.g. U.S., E.U)
- Lead in the coordination, preparation and timely submission of regulatory documents (e.g. INDs, MAAs, NDAs).
- Manage regulatory aspects of Phase 3 and other clinical trials concurrently
- Manage, mentor, and develop direct reports
- Write regulatory documents to support regulatory agency submissions
- Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
- Establish relevant processes and procedures to support the Regulatory Affairs function activities
- Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
- Ensure compliance with regulatory requirements
- Bachelor's degree
- 6+ years pharmaceutical industry experience with a minimum of 4 years in CMC Regulatory Affairs
- Upward progression in role and leadership abilities.
- Experience leading teams or projects.
- Advanced degree in chemistry, biochemistry, or pharmacy
- Experience managing and developing direct reports
- Evidence of successful CMC submissions to FDA (e.g., INDs, briefing packages)
- Demonstrated evidence of writing of CMC regulatory documents
- Knowledge of FDA and ICH CMC regulations and guidelines a must, knowledge of EU and/or Japan CMC regulations desirable
- Knowledge of drug development
- Excellent written and oral communication skills
- Excellent interpersonal skills