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Global Product Registrar

2 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

Regulatory Affairs Specialist

About the Job:

Cpl Healthcare is seeking a highly skilled Regulatory Affairs Specialist to join our team in Dublin. As a key member of our team, you will play a crucial role in ensuring compliance with EU regulations and standards.

Main Responsibilities:

  • Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.)
  • Prepare and file the EU submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, marketing authorisation transfers
  • Write local modules (ex: module 1) and administrative documents
  • Compile regulatory documentation received from other departments (CMC, clinical) for DCP, MRP and national applications in line with assigned timelines (including responses to questions)
  • Effective high-quality communication with European Regulatory Authorities, participate in meetings with health authorities as needed
  • Follow-up of the submissions with HA

Requirements:

  • Lifescience qualification
  • 2-3 years of experience in Regulatory Affairs, in particular good knowledge of EU procedures (DCP, MRP)
  • Ability to multi-task

Additional Requirements:

  • Ability to communicate with colleagues in global countries
  • Autonomy, multi-tasking abilities