**Regulatory Affairs Officer Opportunity at Thornshaw Scientific**
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 filling, 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).
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.
Skills:
* Regulatory.
* Regulatory affairs.
* RA.