Job Description
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 EU-appropriate strategies
- 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
Requirements include:
- Advanced degree in a scientific field
- 8+ years of 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 with the EMA and national regulatory agencies
Regeneron is a leading biotechnology company dedicated to harnessing the power of biology to deliver innovative treatments to patients worldwide.