Under the leadership of the Director/Senior Director, CMC Regulatory Affairs the incumbent manages the global regulatory CMC activities except Asia for all our client’s projects, provides strategic CMC regulatory guidance during drug development, approval, post approval, and commercialization, in coordination with internal staff and external consultants/contractors. Manages the development and preparation of high quality CMC sections of the regulatory submissions including NDA’s, MAA’s, INDs, CTAs, DMFs, ASMFs, etc., and ensures that they conform to current GMP and global regulatory requirements. The incumbent interacts with regulatory authorities during the drug development and approval processes following an agreed upon plan.
Responsibilities and Duties:
Other Skills and Abilities: