Regulatory Affairs Officer
1 week ago
Thornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now has a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The same company also has Senior Regulatory Affairs Officer opportunities.
Key Responsibilities:- Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical products.
- Prepare and file the EU submissions including life-cycle maintenance variations, initial MAA filing, labelling updates, renewals, marketing authorisation transfers.
- Write the 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.
- Life Science qualification.
- 2-3 years of experience in Regulatory Affairs, particularly good knowledge of EU procedures (DCP, MRP).
- Ability to multi-task.
- Ability to communicate with colleagues in global countries.
- Autonomy, multi-tasking abilities.
For full job spec and discussion, email your CV to ldunne@thornshaw.com or call Tina at +353 1 2784703. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
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