Regulatory Affairs Specialist
4 days ago
Thornshaw Scientific, in collaboration with a global pharmaceutical company, is seeking an experienced Regulatory Affairs Specialist to join the Dublin team.
The role presents an opportunity for individuals with a strong background in EU regulatory affairs to contribute to the development and maintenance of marketing authorisation dossiers and submissions.
Key Responsibilities:
- Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.)
- Prepare and file the EU submissions including life-cycle maintenance variations, initial MAA filing, labelling updates, renewals, marketing authorisation transfers
- Compile regulatory documentation received from other departments (CMC, clinical) for DCP, MRP and national applications in line with assigned timelines
- 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:
- 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
This role requires a skilled professional who can effectively navigate EU regulatory requirements and collaborate with cross-functional teams to ensure compliance and timely submission of regulatory documents.
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