Regeneron seeks an Associate Director to lead EU regulatory team members, build representation of Regeneron's EU regulatory function, and develop strategies for EU-appropriate development products.
A typical day involves leading EU regulatory team members, building representation of Regeneron's EU regulatory function, developing strategies for EU-appropriate development products, and executing clinical trial applications.
The ideal candidate has an advanced degree in a scientific field, 8+ years of regulatory experience, experience leading and developing staff members, and experience with the EMA and national regulatory agencies.
Key responsibilities include:
- Leading, handling, and developing EU regulatory team members
- Building representation of Regeneron's EU regulatory function to EMA and EU National Agencies
- Assisting Development teams in developing strategies that are EU-appropriate
- Executing clinical trial applications for assigned programs
- Providing support to department liaisons with project-specific communications and issues
- Monitoring emerging legislation and guidance in the EU
Regeneron is a leading biotechnology company dedicated to harnessing the power of biology to deliver innovative medicines that transform lives.
The ideal candidate will have:
- Advanced degree in a scientific field
- 8+ years regulatory experience with a focus on supporting products through clinical development
- Experience leading and developing staff members
- Consistent record of supporting EU Clinical Trial Applications through approval and study start up
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs)
- Experience of bringing a product through EU approval
- Ability to negotiate and concisely express clear positions to stakeholders