Director, Regulatory Affairs
A commercial-stage biopharmaceutical company who works to develop innovative medicines for patients suffering from rare diseases are looking to add a Regulatory Affairs Director to their team. Their patient-centered approach has allowed them to create cutting-edge treatments for diseases that have very few treatment options!
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.