We are looking for a proven Pharmaceutical Director of Regulatory Affairs to work with our team to develop a regulatory strategy, getting a product approved. If you are looking to join a growing company with the pleasure of working from home, continue reading.
Some of your responsibilities include:
- Lead FDA meetings
- Post-approval activities
- Developing strategy for submission
- Post approval process
- Prep and maintain Prior Approval Supplements (PAS), New Drug Applications (NDA), Biologics License Applications (BLA)
- Manage Contract Research Organizations (CMO)
- Labeling
Travel: once a month, meeting team occasionally, site visits
Experience Requirements:
- Over 10 years pharmaceutical regulatory experience
- Over 5 years drug/biologics experience
- Bachelor’s in scientific discipline
- Managing New Drug Application (NDA) and Biological License Application (BLA)
- Experience with animal derived products
- Understanding science of peptides and protein products
- Sterile injectables
- Electronic Common Technical Document (eCTD)
