Manager, Regulatory Affairs

Role: Regulatory Affairs Manager responsible for managing, evaluating, and executing regulatory submissions across clinical, non-clinical, and CMC areas to support product development and registration. Objectives include developing regulatory strategies to facilitate early approvals and ensuring compliance with global regulatory requirements. Responsibilities involve preparing and reviewing dossiers such as INDs, amendments, BLAs/NDAs, annual reports, and safety reports; coordinating with cross-functional teams; and maintaining regulatory documentation. Qualifications: 7+ years’ experience in regulatory affairs with a BA/BS degree; expertise in IND preparation, CTD/eCTD formats, and FDA regulations; knowledge of GMP, GCP, and GLP; excellent communication and planning skills; detail-oriented and self-motivated. Preferred: experience with NDAs/supporting amendments, international regulatory knowledge, and familiarity with Adobe Acrobat. High-Value: focus on cancer therapeutics, product registration in US and abroad, and experience supporting clinical development phases. Work setup details are not specified, but role implies a fast-paced, entrepreneurial environment requiring broad regulatory responsibilities.