Regulatory Affairs Director EU

2 weeks ago


Dublin, Dublin City, Ireland Emergent BioSolutions Full time
About the Role

This is an exciting opportunity to join our team as a Director, Regulatory Affairs EU, where you will play a critical role in overseeing regulatory activities across our product portfolio. As a key member of our organization, you will provide strategic direction to the business and other stakeholder functions, ensuring compliance with EU & global regulations.

Key Responsibilities:
  • Direct and develop a regulatory group located across Emergent sites or remotely;
  • Develop and lead regulatory strategy for the EU and global, for Emergent products;
  • Provide regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products with a focus on EU and/or UK requirements;
  • Direct efforts for planning and execution of required regulatory filings;
  • Work with project teams to resolve complex project issues, utilizing regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained;


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