GQR Life Sciences is currently recruiting an experienced Director, Global Regulatory Affairs CMC for a rapidly growing biotech based in South San Francisco. The company is seeking motivated team players with small molecule and both development and post-approval experience to join their growing regulatory affairs team. **relocation covered**
- Support CMC reg affairs activities for products in development
- Act as point of contact with regulatory agencies on CMC activities
- Provide CMC regulatory guidance and strategy to development teams
- Contribute to the preparation, review, and submission of documents to regulatory authorities including FDA and global authorities to support clinical trials and marketing applications.
Coordinate with Regulatory, QA, and Development and other functional areas to develop and implement CMC Reg Strategy.
This is an exciting opportunity for a Director, Regulatory Affairs CMC to work with an innovative company transforming science. The company has a great reputation and impressive growth plans. Now is the time to join their team!
Apply now by sending an up-to-date CV to firstname.lastname@example.org or call Nicole Leinders at 917 460 0157.
5+ years years experience in CMC Regulatory Affairs
Experience in preparation and submission of CMC components of IND/CTA/NDA/MAAS/post-approval supplements/variations BA/BS required
Start Date: ASAP
Location: San Francisco