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Senior Regulatory Affairs Lead, CMC Biologics

Parexel, Indiana, PA, United States


A global biopharmaceutical company is seeking a Senior Regulatory Affairs Associate to manage regulatory submissions and ensure compliance for Biologicals, Vaccines, and other products. Candidates should have 5 to 8 years of relevant experience and a solid understanding of regulatory frameworks in various regions. Responsibilities include preparing and reviewing Marketing Authorization Applications in multiple markets including the US and EU, as well as collaborating effectively within a team and working independently. #J-18808-Ljbffr