Global Regulatory Affairs Specialist

24 hours ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €118,000 - €138,500

Job Overview

We are seeking a highly skilled professional to ensure global regulatory compliance by aligning with external requirements and internal quality procedures. The successful candidate will be responsible for demonstrating regulatory expertise, sharp decision-making, and collaboration to develop and execute regulatory strategies, manage submissions, and review policies.

The role will involve creating and executing robust regulatory strategies to mitigate risks and address technical and scientific challenges. Key responsibilities include preparing and delivering high-quality CMC submissions to global regulatory agencies, managing timelines, and ensuring alignment with regulatory commitments.

The ideal candidate will have an effective combination of the following qualifications, skills, and experiences:

  • Degree in Natural Sciences with 6 years pharmaceutical experience and a minimum of 3 years pharmaceutical regulatory experience
  • At least 2+ years of hands-on CMC authoring experience, including initial registrations or post-approval variations
  • Solid understanding of cGMPs, development, and commercial activities to assess the technical and regulatory merits of CMC data
  • Knowledge of global regulatory requirements, submission processes, and interactions with regulatory authorities
  • Proven ability to interpret and apply global and regional CMC guidelines to shape strategic regulatory directions
  • Awareness of emerging scientific and manufacturing technologies and their application in regulatory strategies

Our organization offers competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.

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