GQR Life Sciences is currently recruiting an experienced Director, Global Regulatory Affairs CMC for a rapidly growing biotech based in San Diego and New Jersey. The company is seeking motivated team players with small molecule and post-approval experience to join their growing regulatory affairs team. **relocation covered**
Support CMC reg affairs activities for compounds 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, European Medicines Agency (EMA) and other national authorities to support clinical trials and marketing applications.
Assist in evaluation of manufacturing processes and changes, contributes to the assessment of regulatory implications and supporting their implementation.
Coordinate with Regulatory, QA, and Development and other functional areas to develop and implement CMC Reg Strategy.
This is an exciting opportunity for an 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 Diego or North Jersey