EU Marketing Authorisation Specialist
4 days ago
We are seeking a highly skilled EU Marketing Authorisation Specialist to join our team at Thornshaw Scientific, in partnership with a prominent global pharmaceutical company.
About the PositionThe ideal candidate will be responsible for managing EU marketing authorisation dossiers and submissions, including lifecycle activities, variations, transfers, and renewals. Key tasks will involve preparing and filing EU submissions, writing local modules, and compiling regulatory documentation from other departments.
This role demands effective communication with European Regulatory Authorities, participation in meetings with health authorities, and follow-up on submissions with HA. To succeed 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.
Main Responsibilities- Develop and implement strategies for managing EU marketing authorisation dossiers and submissions.
- Prepare and file EU submissions, including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, and marketing authorisation transfers.
- Author local modules (e.g., module 1) and administrative documents.
- Coordinate regulatory documentation 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).
- Excellent communication skills and ability to work effectively with colleagues in global countries.
- Autonomy and multi-tasking abilities.
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