Senior Regulatory Affairs Officer, Dublin
Thornshaw Scientific, in collaboration with our client, a global pharmaceutical company, is offering a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The company also has openings for Senior Regulatory Affairs Officers.
Key Responsibilities:
1. Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer, etc.) for our current portfolio of pharmaceutical products.
2. Prepare and file EU submissions, including lifecycle maintenance variations, initial MAA filings, labelling updates, renewals, and marketing authorisation 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 multitask effectively.
* Excellent communication skills for liaising with colleagues across global locations.
* Autonomy and strong multitasking abilities.
For the full job specification and to discuss further, please email your CV or contact Linda at 1. Thornshaw Scientific is a division of the CPL Group.
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