Pharmaceutical Regulatory Compliance Specialist

6 days ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €125,000

Job Summary

The Regulatory Affairs Manager role is a key position that involves leading and managing regulatory projects to ensure high-quality compliance and effective communication with stakeholders.

  • This includes responsibility for assigned operational registration and life-cycle management projects for company products.
  • The successful candidate will also be responsible for preparation and submission of regulatory documents, including Marketing Authorization Transfer, CMC variation filing, and initial MAA filing.

Key Qualifications

To be considered for this role, candidates must have:

  • A pharmacy or scientific primary and/or advanced degree.
  • More than 5 years of human pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets.
  • Excellent communication skills and project management experience.

Benefits

Candidates who possess a strong understanding of EU DCP and MRP MAAs, as well as experience with writing and preparation of relevant CTD documents, are highly desirable. The ideal candidate will also have excellent communication skills and be able to work effectively in a global multi-stakeholder environment.



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