Regulatory Affairs Mgr

The Japan Regulatory Strategy Manager at Amgen develops and executes regulatory strategies to obtain and maintain clinical trial and marketing licenses for the company's molecules in Japan. This role involves providing strategic regulatory expertise, interfacing with local authorities like the PMDA and MHLW, and aligning Japan's regulatory plans with global strategies. The position requires close collaboration with cross-functional teams to support drug development, clinical studies, and regulatory submissions while ensuring compliance with local and corporate standards.