Senior Manager, Regulatory CMC
Raleigh, North Carolina
In this role you have a chance to work with growing global pharmaceutical company that is breaking through neurology and oncology, with a strong emphasis on research and development! They are looking for highly motivated individuals who want to join a dynamic and fast-paced organization!
Responsibilities
- Develop and implement regulatory CMC strategies throughout the lifecycle of biologics and pharmaceuticals
- Identify potential CMC issues and effectively communicates them to the CMC team
- Organize and prepare NDA's MMAs and Growth market dossiers
- Prepare and lead CMC authoring meetings
Qualifications
- Bachelor's Degree
- 8+ years of experience in the pharmaceutical industry
- Knowledge of CTD dossier (module 2.3 and 3) strongly preferred
- Biologics experience is a plus
