Principal Scientist (Director) - Regulatory Affairs-CMC

Job description

Job Description Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5) Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc Principal scientist in support of their assigned projects. Position Description: The Principal Scientist / Director responsibilities include but are not limited to: Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in development or commercial products. In depth knowledge and application of global CMC guidelines regarding IND/BLAs or post approval...