Job Description
As a Regulatory Affairs Officer at Thornshaw Scientific, you will play a crucial role in ensuring compliance with EU regulations and guidelines for pharmaceutical products.
Main Responsibilities:
* Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfers) for our portfolio of pharmaceutical products.
* Prepare and file EU submissions, including life-cycle maintenance variations, initial MAA filing, labelling updates, renewals, and marketing authorisation transfers.
* Write local modules (e.g., module 1) and administrative documents.
* Compile regulatory documentation from other departments (CMC, clinical) for DCP, MRP, and national applications, adhering to assigned timelines.
Key Requirements:
* Lifesciences qualification
* 2-3 years of experience in Regulatory Affairs, with a strong understanding of EU procedures (DCP, MRP)
* Ability to multitask and work independently
* Effective communication skills, particularly with colleagues in global countries