Lead, Regulatory Affairs CMC Director
As one of the top largest and fastest growing pharmaceutical companies in the US- across multiple therapeutic areas with candidates in Development, Clinical and Market-Place stages, they are looking to fill a Lead, Regulatory Affairs Director CMC position on the Plasma Derived Therapies Team ! If you have strong CMC development strategy experience (Pre IND, Phase 1, Phase 2), Biologics, understands Global Regulatory CMC regulations and guidelines, and can be in direct contact with international Health Authorities (EMA/FDA/ICH/WHO/ Global regulations), please apply!
In this role you will be responsible for:
- Developing and leading all global CMC strategies
- Ensuring global strategies are successfully executed across both new product development and existing portfolio life cycle management.
- Creating high quality, compliant CMC regulatory documents (eg, Core Dossiers, CTAs, MAAs, NDS, Variations and other relevant regulatory CMC filings) Account for the global cross-functional teams for FDA/EMA/ICH/WHO Global Regulations
- Acting as the direct point of contact with health authorities by leading and managing all FDA/health meetings
The client requires that all candidates have:
- Minimum of 9 years of experience in global drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities
- At Least 6 years in a Regulatory CMC role
- At least 3 years in a Regulatory Affairs CMC Leadership role
- Regulatory US and International Product Development experience
- Strong CMC Strategy and Submission experience
- Understanding all global Regulatory implications
- Previous Plasma Derived Therapies is not required