Regulatory Affairs Professional
4 days ago
At Thornshaw Scientific, our collaboration with a leading global pharmaceutical company has led to an exciting opportunity for a skilled Regulatory Affairs Officer to join our Dublin team.
About the RoleThe successful candidate will be responsible for managing EU marketing authorisation dossiers and submissions, including lifecycle activities, variations, transfers, and renewals. Key tasks will include preparing and filing EU submissions, writing local modules, and compiling regulatory documentation from other departments.
This role requires effective communication with European Regulatory Authorities, participation in meetings with health authorities, and follow-up on submissions with HA. To excel in this position, you must possess strong knowledge of EU procedures (DCP, MRP) and have at least 2-3 years of experience in Regulatory Affairs.
Key Responsibilities- Manage EU marketing authorisation dossiers and submissions, including lifecycle activities, variations, transfers, and renewals.
- Prepare and file EU submissions, including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, and marketing authorisation transfers.
- Write local modules (e.g., 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.
- Lifescience qualification.
- 2-3 years of experience in Regulatory Affairs, particularly good knowledge of EU procedures (DCP, MRP).
- Ability to multi-task and communicate effectively with colleagues in global countries.
- Autonomy and multi-tasking abilities.
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