R&D - GRA - Regulatory Affairs Manager - BJ

**Job Title:** Regulatory Affairs Manager, I&I Alliance

**Reports to:** TA Head, I&I Alliance, China

**Team Management:** Individual Contributor

**Key Responsibilities:**

**China – I&I Alliance**

+ Support the development and implementation of appropriate regulatory strategies for I&I Alliance products in China, under the guidance of the TA Head.
+ Lead cross-functional teams to ensure timely submission and delivery of Marketing Authorisations in China in line with agreed strategy, and manage the consequent lifecycle management activities.
+ Manage regulatory processes effectively and in compliance with internal standards and regulatory requirements, ensuring appropriate dossier quality for submissions and overall regulatory compliance in China.
+ Establish effective coordination of regulatory activities in China, supporting cooperation with the China Business Unit and Global divisions.
+ Work across project teams to evaluate ...