Associate Director, Global Regulatory Affairs, CMC Authoring (Remote)
BioNTech
- Cambridge, MA
- Permanent
- Full-time
- Author global quality regulatory documentation for multiple project(s) in a timely manner and according to the relevant procedures.
- Support definition and establishment of platform approaches to preparation of quality regulatory documentation used in development, registration and post-approval stages
- Support alignment of structure and contents of quality regulatory documentation across company platforms
- Contribute to development of regulatory CMC strategy for the assigned project(s)
- Liaise with relevant stakeholders to facilitate preparation of quality regulatory documentation of the highest quality and strive to optimize/simplify the authoring processes and shorten the authoring times
- Degree in biochemistry, biology, chemistry, pharmacy or equivalent
- 5+ years of professional experience in global regulatory affairs CMC focusing on Biologics, Vaccines and/or Small Molecules
- Extensive experience in authoring of regulatory CMC documents for clinical trial applications (e.g., quality parts of INDs/IMPDs) and/or marketing authorisations (e.g., quality parts of variations, BLAs, MAAs)
- Solid knowledge of product life cycle management and understanding of scientific principles and regulatory CMC requirements relevant to global drug development
- Very good knowledge of the relevant laws and guidelines
- Organisational talent, analytical and conceptual skills as well as excellent communication skills in English (written and spoken)