Regulatory Affairs Officer sought to manage EU marketing authorisation dossiers and submissions for pharmaceutical products, ensuring compliance with EU procedures and regulations.
Thornshaw Scientific, a division of the CPL Group, collaborates with a global pharmaceutical company to deliver high-quality regulatory services.
Key Responsibilities:
- Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for current portfolio of pharmaceutical products.
- Prepare and file EU submissions, including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, marketing authorisation transfers.
- Write 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.
- Effective high-quality communication with European Regulatory Authorities, participate in meetings with health authorities as needed.
- Follow-up of submissions with HA.
Requirements:
- Life Science qualification.
- 2-3 years in experience in Regulatory Affairs, in particular good knowledge of EU procedures (DCP, MRP).
- Ability to multi-task.
- Ability to communicate with colleagues in global countries.
- Autonomy, multi-tasking abilities.
Thornshaw Scientific is a leading provider of regulatory services to the pharmaceutical industry, with a strong reputation for delivering high-quality solutions.