Global Regulatory Affairs Specialist

3 days ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €101,000
Global Regulatory Affairs Specialist

We are seeking a skilled Global Regulatory Affairs Specialist to join our team.

This role involves demonstrating regulatory knowledge and experience, balanced judgment, crisp decision-making, exemplary collaboration, and business acumen. The successful candidate will develop robust regulatory strategies, prepare and deliver high-quality CMC regulatory submissions & submission management plans for global regulatory agencies.

  • Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) is required.
  • The ideal candidate should have sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP's required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).

This position requires strong technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden, and improve regulatory flexibility commensurate with business needs.



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