Associate Director, Regulatory Affairs - Regeneron Pharmaceuticals, Inc
  • Dublin, Leinster, Ireland
  • via BeBee.com
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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 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

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