Director, Regulatory Affairs
My client, a commercial-stage biopharmaceutical company works to develop innovative medicines for patients suffering from rare diseases. Their patient-centered approach has allowed them to create cutting-edge treatments for diseases that have very few treatment options! They are looking to add a fully remote Regulatory Affairs Director to their team!
The Regulatory Affairs Director will be responsible for:
- Preparing regulatory documents such as IND, NDA, annual reports, and briefing books.
- Day-to-day communication with regulatory agencies.
- Participating in regulatory strategy determination and implementing strategies decided by the team based on clinical trial data, current regulations, and the regulatory landscape of competitors.
- Provide regulatory support to the VP to appropriately communicate regulatory updates and milestones to management.
The Regulatory Affairs Director should have the following qualifications:
- B.S. in Biological Sciences and 10+ years Regulatory experience.
- 3 years of experience building, training, and working closely with regulatory team members.
- Hands on experience with IND and NDA submissions and response to FDA's questions.
- Knowledge of relevant FDA regulations and guidelines.