Associate Director, Regulatory CMC
My client, a global industry leading pharmaceutical company focuses on providing innovative solutions for underserved patient populations in a variety of therapeutic areas. My client is looking to add a Regulatory CMC Associate Director to their team!
The Associate Director of Regulatory CMC will be responsible for:
- Providing strategic regulatory guidance on projects including general CMC regulatory strategies, regulatory CMC requirements for clinical studies and marketing approval
- Overseeing and leading the preparation/submission of documentation to support registration packages throughout the world and ensuring timelines are met
- Reviewing CMC sections of NDA/BLA/MAA, IND/CTA and other global submission documents to support clinical trials and marketing applications in conformance with local regulatory requirements
- Applying knowledge of US, EU and ICH regulatory requirements both strategically and operationally to marketed product regulatory issues and development projects to support corporate goals
- Articulating regulatory CMC issues and supporting global development/commercialization of early and late-stage programs