Job Category: Clinical: Regulatory
Job Number: 2659
Our client is currently expanding its Regulatory team to support late-phase clinical assets and is searching for an Associate Director, Regulatory Affairs to support the continued development of our client’ s therapy in the treatment of anemia. This individual will operate in a high-visibility role and will be responsible for developing and coordinating regulatory strategies and leading NDA/MAA preparation and submission to regulatory agencies. In this position, they will partner with the Clinical, Medical, Program Management and Alliance Management groups to move this work forward.
- Design and support implementation of well-informed global regulatory strategies
- Represent Regulatory Affairs 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
Requirements / Qualifications:
- Bachelor' s degree; Advanced degree in chemistry, biochemistry, or pharmacy preferred
- 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.
- 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
- Strong project management skills and drive for excellence