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Regulatory Affairs Officer - Dublin
Thornshaw Scientific, in collaboration with a global pharmaceutical company, is seeking a Regulatory Affairs Officer to join their Dublin team. The company also offers Senior Regulatory Affairs Officer opportunities.
Key Responsibilities:
1. Manage EU marketing authorization dossiers and submissions (MAAs, lifecycle activities, variations, transfer, etc.) for 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 timely responses 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 and work independently.
* Excellent communication skills with colleagues across global locations.
For the full job description and to discuss further, please email your CV or contact Tina at [phone number]. Thornshaw Scientific is a division of the CPL Group.
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