Associate Manager, US Regulatory Affairs

Role: Senior Associate in Regulatory Affairs responsible for managing, evaluating, and executing regulatory projects to support cancer therapies. Primary objectives include ensuring timely regulatory submissions, developing strategies for approvals, and maintaining compliance with global regulatory requirements. Responsibilities encompass preparing, reviewing, and submitting regulatory dossiers such as INDs, amendments, BLAs/NDAs, and annual reports across clinical, non-clinical, and CMC areas; guiding cross-functional teams on regulatory strategies; and maintaining regulatory documentation and archives. Qualifications: BA/BS in Health Science or related field; 4+ years in pharma/regulatory affairs with experience in INDs, NDAs, amendments, and CTD/eCTD publishing; strong knowledge of FDA and ICH guidelines, GMP, GCP, GLP; excellent communication and planning skills; detail-oriented and self-motivated. Preferred: experience with multiple regional regulatory agencies, regulatory strategy development, and working in fast-paced, entrepreneurial environments. High-Value: focus on cancer therapeutics, with involvement in investigational and registration stages, compliance with GxP, and collaboration with external consultants/CROs. Work Setup: not specified, but implied to be in an environment supporting cross-functional, regulatory activities.