The Director - Regulatory Affairs will have responsibility for the following:
- Overseeing the preparation, development and implementation of global regulatory submission strategies (IND/NDA) with responsibility for both US as well as European regulatory submissions.
- Serving as the primary contact person with both the FDA and/or EMA with regards to IND/NDA submissions.
The Director - Regulatory Affairs should have a strong background in Regulatory Affairs and have the ability to provide Regulatory Affairs advice at all levels of the organization.
The Qualified Candidate will have a degree in Pharmaceutical Sciences or related - preferably an advanced degree (Masters, Pharm.D., M.D., Ph.D. etc.)
The Qualified Candidate will also have a strong scientific background with at least 5+ years of Regulatory Affairs experience (primarily with IND/NDA submissions).