Regulatory Affairs Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeExpertise Full time €96,722 - €137,324
Job Opportunity

The Manager, Regulatory Affairs Global CMC role plays a pivotal part in ensuring global regulatory compliance by aligning with external requirements and internal quality procedures.

  • Ensure global regulatory compliance by managing regulatory submissions and reviewing policies.
  • Demonstrate regulatory expertise and sharp decision-making to develop and execute regulatory strategies.
  • Create and execute robust regulatory strategies to mitigate risks and address technical and scientific challenges.

Key Responsibilities:

  • Prepare and deliver high-quality CMC submissions to global regulatory agencies, managing timelines and ensuring alignment with regulatory commitments.
  • Serve as a CMC representative, managing project activities, assessing risks, and developing global regulatory strategies.
  • Support post-approval changes, new registrations, renewals, and responses to agency queries while performing quality reviews of CMC submissions.

About Your Skills & Experience:

  • Effective combination of a degree in Natural Sciences, pharmaceutical experience, relevant technical experience (Quality, Technical Services, R&D), and a minimum of 3 years pharmaceutical regulatory experience required.
  • At least 2+ years of hands-on CMC authoring experience, including initial registrations or post-approval variations.

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