Senior Director - Regulatory Affairs CMC Small Molecule
We are currently looking for a Senior Director of Global Regulatory Affairs (GRA) CMC for a client in the pharmaceutical industry. The successful candidate will be responsible for the early development of small molecule drugs and will be based in Boston, Massachusetts. Candidate must be able to go on-site.
Responsibilities
- Oversee and lead the development of global regulatory CMC strategies for small molecule drugs
- Collaborate with cross-functional teams to ensure that regulatory CMC requirements are met
- Provide technical expertise and guidance to ensure that regulatory CMC strategies are in line with global regulatory guidelines
- Ensure that regulatory CMC submissions are of high quality and are submitted on time
- Build and maintain strong relationships with regulatory authorities
Skills
- Extensive experience in early development of small molecule drugs
- Strong knowledge of global regulatory CMC guidelines
- Excellent leadership and communication skills
- Ability to work collaboratively with cross-functional teams
Additional Information
- Small molecule experience is required
- 15 years of experience in pharmaceutical and global health authority experience
- Extensive early development experience is required
- Management experience
