Regulatory Affairs Professional
Thornshaw Scientific, in collaboration with a global pharmaceutical company, now have an opportunity for a Regulatory Affairs Officer to join the team.
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).
* Effective high-quality communication with European Regulatory Authorities, participate in meetings with health authorities as needed. Follow-up of the 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
Benefits:
* Fully-funded training and development opportunities
* A supportive work environment with regular feedback
* Collaborative team dynamic with diverse backgrounds