Japan Regulatory Strategy Group Senior Manager

**Group Purpose**

Japan Regulatory Affairs provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities and global regulatory strategy. The group also obtains and maintains local pharmaceutical company licenses and foreign manufacturing accreditation.

**Job Summary**

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross-functional partners; integrating into Amgen’s commercialization process; continuously improving business processes; and developing our talent.

The Japan Regulatory Strategy Group Sr Mgr may be assigned to multiple Amgen products for product-specific activities.
The Japan Regulatory Strategy Group Sr Mgr has ...