A global pharmaceutical company is looking for a Senior Director of Regulatory Affairs to join their team. This individual will be a go to contributor in maintaining approval of marketed products and continuing compliance with Regulatory Health Authorities worlwide.
- Coordinate with Regulatory Health Authorities in support of drug applications and filings
- Act as a leader in the filing of IND, NDA, CTA, BLA, MAA
- Develop, organize, and evaluate all non-clinical and clinical activities
- Maintain a working knowledge of changes by Health Authorities around the world
- Knowledge of the Oncology space is a plus
- 10-12 years in Regulatory Affairs
- Experience in Clinical Regulatory and CMC
- Hands on experience working with all aspects of IND, NDA, CTA, BLA, MAA
If you are interested in learning more about this opportunity, please apply here.