Manager Regulatory Affairs
Hybrid - Salt Lake City, Utah
My leading pharmaceutical client is seeking a Manager of Regulatory Affairs based in Salt Lake City, Utah. The role is hybrid and can be flexible. My client is a global leader in generic and specialty medicines with an impressive portfolio of over 3,500 products covering all therapeutic areas.
This position is responsible for successfully filing original Abbreviated New Drug Application submissions (ANDA). This person will ensure comprehensive filings for FDA review and will act as the primary contact with regulatory authorities for assigned projects and products.
The ideal candidate will have experience in development of both complex and non-complex generics across a multitude of dosage forms including combination products. They will have managerial experience and be able to lead meetings.
- Prepare, review and approves regulatory submissions to the FDA to ensure compliance with applicable regulations and guidance.
- Assess risks throughout R&D, filing, deficiency rounds and post-approval.
- Ability to work on multiple projects at once including early stage research and development, filing phase, deficiency rounds, and post-approval.
- S. Degree required
- MS Degree preferred
- 6+ years regulatory experience in pharmaceuticals required
- RAC preferred
Please don't hesitate to reach out and apply! If you know of anyone in your network who could be a good fit - please share!