Regulatory Affairs Director

2 days ago


Dublin, Dublin City, Ireland Emergent Biosolutions Full time

**About the Role**

We are seeking a highly experienced Regulatory Affairs Director to lead our EU regulatory strategy and ensure compliance with global regulations.

The successful candidate will have a strong understanding of the EU regulatory environment and be able to develop and implement effective strategies to obtain and maintain product licenses.

Key Responsibilities:

  • Develop and implement regulatory strategies for EU and global markets
  • Provide guidance on regulatory requirements and ensure compliance across all product portfolios
  • Liaise with health authorities, including EMA and MHRA
  • Lead cross-functional teams to resolve complex project issues

Requirements

  • 12+ years of experience in Regulatory Affairs, preferably in biotechnology or pharmaceutical industry
  • Strong knowledge of EU and global regulations, including ICH, FDA, HC, UK, and EU regulations
  • Excellent strategic thinking, diplomacy, negotiation, and communication skills

About Emergent Biosolutions

We are a leading biopharmaceutical company focused on protecting and enhancing 1 billion lives by 2030. Our mission is to improve the quality of life for individuals around the world by developing innovative products that address unmet medical needs.



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