Senior Associate - Regulatory Affairs

Role: Senior Associate in Regulatory Affairs supporting Amgen's global regulatory functions. Objectives: ensure regulatory compliance, assist with submissions, and maintain regulatory documentation for biopharma products. Responsibilities: support regional regulatory activities, prepare IND/MA documentation, maintain regulatory history, review and contribute to strategic plans, coordinate agency communications, and assist with process improvements. Qualifications: Master’s degree or equivalent experience; 2+ years in Regulatory Affairs with life sciences background; experience in regulatory submissions and document management preferred. High-Value: supporting biologics and small molecule products across oncology, inflammation, and rare diseases; involved in IND and MA processes; collaborating with global regulatory teams; supporting regulatory compliance and agency interactions. Work setup: not specified.