Regulatory Affairs Officer
A new opportunity has arisen for a Regulatory Affairs Officer to join our Dublin team in collaboration with a global pharmaceutical company.
Key Responsibilities:
* Manage EU marketing authorisation dossiers and submissions, including lifecycle activities, variations, and transfers, for our current portfolio of pharmaceutical products.
* Prepare and file the EU submissions, including life-cycle maintenance variations, initial MAA filings, labelling updates, renewals, and marketing authorisation transfers.
* Write local modules and administrative documents.
* Compile regulatory documentation received from other departments for DCP, MRP, and national applications, adhering to assigned timelines and responding to questions.
* EFFECTIVELY communicate with European Regulatory Authorities, participate in meetings with health authorities as needed, and follow up on submissions.
Requirements:
* LIFE SCIENCE QUALIFICATION
* 2-3 years of experience in Regulatory Affairs, with a strong understanding of EU procedures (DCP, MRP).
* Ability to multi-task and work independently.
* Excellent communication skills to collaborate with colleagues across global countries.
Please note that this job specification is available upon request. Interested candidates should submit their CV for further discussion.