Senior Manager, Regulatory Affairs

Role: Regulatory Affairs Manager overseeing regulatory projects related to clinical, non-clinical, and CMC areas, with a focus on timely submission and compliance. Responsibilities: plan and coordinate regulatory activities, develop strategies for early approvals, prepare and submit dossiers (INDs, NDAs, amendments, reports) for US and international markets, ensure regulatory compliance, and advise cross-functional teams on regulatory strategies. Requirements: 7+ years' experience, BA/BS degree, expertise in IND and NDA preparation, CTD/eCTD knowledge, familiarity with FDA/ICH guidance, and understanding of GMP, GLP, GCP. Preferred: experience with other regions' regulatory requirements. High-Value: involvement in biologics or small molecule development, regulatory submission management, and global compliance. Work setup: not specified, but emphasizes ability to work independently in a fast-paced environment.