Regulatory Affairs Officer

2 weeks ago

Dublin, Dublin City, Ireland Cpl Full time
Regulatory Affairs Officer - Pharma, Dublin

Client: Cpl

Location: Dublin, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference: ee3c5f424631

Job Views: 4

Posted: 02.05.2025

Expiry Date: 16.06.2025

Job Description:

NEW OPPORTUNITY - Thornshaw Scientific, in collaboration with our client, a global pharmaceutical company, is seeking a Regulatory Affairs Officer to join the Dublin team.

Key Responsibilities:
  1. Manage EU marketing authorization dossiers and submissions (MAAs, lifecycle activities, variations, transfer, etc.) for the current portfolio of pharmaceutical products.
  2. Prepare and file EU submissions, including lifecycle maintenance variations, initial MAA filings, labeling updates, renewals, and marketing authorization transfers.
  3. Write local modules (e.g., module 1) and administrative documents.
  4. Compile regulatory documentation from other departments (CMC, clinical) for DCP, MRP, and national applications, ensuring adherence to timelines and responding to questions.
  5. Maintain effective communication with European Regulatory Authorities and participate in meetings as needed; follow up on submissions with health authorities.
Candidate Requirements:
  • 2-3 years of experience in Regulatory Affairs, with strong knowledge of EU procedures (DCP, MRP).
  • Ability to multi-task effectively.
  • Excellent communication skills with colleagues across global locations.
  • Autonomy and ability to manage multiple tasks independently.

For the full job specification and to discuss further, please email your CV or contact Tina or Linda at [phone number]. Thornshaw Scientific is a division of the CPL Group.

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