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Pharmaceutical Regulatory Affairs Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

Pharmaceutical Regulatory Affairs Expert

About This Position

This position involves providing expert advice on EU pharmaceutical regulations and ensuring compliance with relevant laws and guidelines. The successful candidate will manage EU marketing authorisation dossiers and submissions, prepare and file EU submissions, and coordinate with European Regulatory Authorities.

Main Responsibilities:
  • Manage EU marketing authorisation dossiers and submissions for our current portfolio of pharmaceutical products.
  • Prepare and file EU submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, marketing authorisation transfers.
  • Provide expert advice on EU pharmaceutical regulations and ensure compliance with relevant laws and guidelines.
  • Compile regulatory documentation received from other departments for DCP, MRP and national applications in line with assigned timelines.
Qualifications:
  • Life Science qualification.
  • 2-3 years of experience in Regulatory Affairs, particularly good knowledge of EU procedures.
  • Ability to communicate effectively with colleagues in global countries.

You will be working closely with cross-functional teams, so excellent communication and interpersonal skills are essential.

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