Thornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have opportunities for Regulatory Affairs Officers to join the Dublin team.
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 the EU submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, marketing authorisation transfers.
3. Write the local modules (ex: module 1) and administrative documents.
4. Compile regulatory documentation received from other departments (CMC, clinical) for DCP, MRP and national applications in line with assigned timelines (including responses to questions).
5. Effective high-quality communication with European Regulatory Authorities, participate in meetings with health authorities as needed. Follow-up of the submissions with HA.
Minimum Requirements:
1. Life Science qualification.
2. 2-3 years in experience in Regulatory Affairs, in particular good knowledge of EU procedures (DCP, MRP).
3. Ability to multi-task.
4. Ability to communicate with colleagues in global countries.
5. Autonomy, multi-tasking abilities.
For full job spec and discussion, email your CV to tdunne@thornshaw.com or call Tina or Linda at +353 1 2784701. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com #LI-TD1
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