Associate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics

Job description

Job Description Associate Principal Scientist, Regulatory CMC - Biologics (R4) This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from Director/Executive Director, the Assoc Principal Scientist is responsible for 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 Assoc Principal Scientist is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principal Scientist will assist in the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects. The Associate Principal Scientist / Assoc Director responsibilities include but are not limited to: Participation in the authorization process to prioritize submissions. In depth knowledge of global CMC guidelines regarding IND/BLAs or post approval changes. Completion of detailed, global regulatory assessments according to existing global guidelines and poli...