Associate Director, Regulatory Affairs (Oncology & Rare Disease)

**Corporate Title**

Regulatory Affairs Assoc. Director

**Title (Role)**

Head of Japan Regulatory Strategy for Oncology and Rare Disease

**Specialty**

Regulatory Affairs

**Team**

Local Regulatory Affairs (Japan)

**Function**

Global Regulatory Affairs and Strategy (GRAAS), R&D

**Group Purpose**

Facilitate patient access to Amgen products in Japan through executing on our filing plans; providing strategic regulatory guidance on Japan regulatory mechanisms to optimize product development and approvals; aligning with key cross-functional partners; integrating Amgen’s commercialization process, and continuously improving our processes and developing our talent.

**Job Summary**

**Responsible for:**

+ Provides local input to developing and executing regulatory strategies and effective key regulatory agency interactions
+ Ensures local labels are developed and maintai...