US Regulatory Lead

Role: US Regulatory Lead within Amgen’s Regulatory Affairs team, managing regulatory strategies for one or more medium-complexity products in the US. Responsibilities include aligning local requirements with corporate standards, planning and executing submissions, managing agency interactions, and ensuring product compliance across lifecycle stages. The role involves collaborating with global teams, reviewing labels and promotional materials, and supporting local regulatory processes and research. Qualifications: Doctorate, Master’s (with 3+ years US regulatory experience), Bachelor’s (5+ years), or equivalent, with experience managing teams or projects. Preferred skills include knowledge of drug development, US legislation, regulatory submissions, and agency interactions, especially with the FDA. Deep understanding of regulatory principles, strong communication, negotiation skills, and cultural sensitivity are expected. High-value specifics: Focus on biologics/biotech products in the oncology, inflammation, or rare disease areas, with responsibilities spanning development, registration, and lifecycle management, primarily in the US market. The role may involve cross-functional collaboration with clinical, CMC, and legal teams. Work setup is not specified; travel requirements are not detailed, but the position entails significant stakeholder engagement and strategic oversight.