Director of EU Regulatory Compliance

2 weeks ago

Dublin, Dublin City, Ireland Emergent Biosolutions Full time
About the Opportunity

We are seeking a highly experienced Director of EU Regulatory Compliance to join our team. As a key member of our regulatory affairs team, you will play a crucial role in ensuring the compliance of our products with EU regulations. Your expertise in EU regulations and guidance will help us navigate the complex regulatory landscape and ensure that our products meet all necessary requirements for licensure.

The ideal candidate will possess strong leadership skills, as well as the ability to communicate effectively with cross-functional teams and stakeholders. You will work closely with project teams to resolve complex issues and ensure successful regulatory filings. If you have a proven track record of success in regulatory affairs and are passionate about staying up-to-date on the latest EU regulations, this could be the opportunity for you.

Key Responsibilities:

  • Develop and implement regulatory strategies across Emergent's product portfolio.
  • 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.
  • Represent Regulatory Affairs at cross-functional teams and core teams.
  • Maintain knowledge of regulatory environment, regulations and guidance's.

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