Thornshaw Scientific collaborates with a global pharmaceutical company to offer opportunities for Regulatory Affairs Officers in the Dublin team.
Key Responsibilities:
* Manage EU marketing authorisation dossiers and submissions, including lifecycle activities, variations, transfers, and initial MAA filings for our current portfolio of pharmaceutical products.
* Prepare and file EU submissions, including life-cycle maintenance variations, labelling updates, renewals, and marketing authorisation transfers.
* Write local modules and administrative documents.
* Compile regulatory documentation received from other departments, including CMC and clinical, for DCP, MRP, and national applications, adhering to assigned timelines.
Requirements:
* Lifesciences qualification
* 2-3 years of experience in Regulatory Affairs, particularly knowledge of EU procedures (DCP, MRP)
* Ability to multitask and communicate effectively with colleagues globally
The ideal candidate will possess autonomy, strong organisational skills, and be able to work efficiently in a dynamic environment.