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Senior Director, Global Regulatory Affairs - CMC (Biologics)

Generate:Biomedicines, Somerville, MA, United States


A biomedicines company in Somerville, MA, is seeking a Director of Regulatory Affairs to lead global regulatory strategy for CMC and clinical programs. The ideal candidate has over 10 years of experience in Regulatory Affairs within biotech or pharmaceuticals, with expertise in global submissions and Health Authority interactions. This strategic role involves close collaboration with various departments to support product development while ensuring compliance with regulatory standards. A hybrid work model is in place, requiring on-site presence 2-3 days per week. #J-18808-Ljbffr