Manager, Regulatory Affairs - Japan
R
Regeneron Pharmaceuticals
📍 Minato-Ku, Japan, Japan
Job Description
As part of our global expansion, we are now looking for in-country regulatory professionals to join our growing global regulatory team. This is an exciting opportunity to demonstrate your knowledge in leading regulatory processes for biological products and regenerative medicines in Japan, and to build Regeneron’s profile with key stakeholders locally.
In this unique position you will interact with a wide and diverse range of colleagues across Regeneron, both locally, and globally.
**Key duties:**
+ Execute the timely submissions of marketing applications and post-approval changes for assigned projects
+ Work with Japan Regulatory Lead to manage and oversee interactions with Japanese regulatory authorities
+ Maintain extensive knowledge of Japan’s Submission Requirements
+ Ensure compliance with Japan’s regulatory requirements and all appropriate local standards
+ Lead/support the timely prepar...
In this unique position you will interact with a wide and diverse range of colleagues across Regeneron, both locally, and globally.
**Key duties:**
+ Execute the timely submissions of marketing applications and post-approval changes for assigned projects
+ Work with Japan Regulatory Lead to manage and oversee interactions with Japanese regulatory authorities
+ Maintain extensive knowledge of Japan’s Submission Requirements
+ Ensure compliance with Japan’s regulatory requirements and all appropriate local standards
+ Lead/support the timely prepar...