Senior Manager/Manager, Regulatory Affairs

Role: Associate Director/Senior Manager, Regulatory Affairs, based in Germantown, MD, supporting global drug development and regulatory strategies. Responsibilities: manage daily regulatory activities for investigational and commercial drugs, serve as liaison with FDA and international agencies, develop and execute regulatory strategies aligned with development and marketing goals, contribute to IND/BLA preparation, review technical documentation, and monitor evolving regulations. Collaborate with cross-functional teams across quality, CMC, preclinical, and clinical programs to ensure compliance and risk mitigation. Qualifications: bachelor's degree in life sciences (advanced degree preferred), 5+ years in biotech/pharma regulatory affairs, deep knowledge of global regulations, experience with eCTD submissions. HighValue: regulatory strategy for biologics/pharmaceuticals, IND/BLA submissions, global compliance, cross-functional collaboration, and risk management. WorkSetup: office-based with some lab and manufacturing access; some travel required.