Regulatory Affairs Specialist
We are seeking a skilled Regulatory Affairs Specialist to join our team in Dublin. This role involves managing EU marketing authorisation dossiers and submissions, including lifecycle activities, variations, transfers, and more.
The ideal candidate will have a Life Science qualification and 2-3 years of experience in Regulatory Affairs, with a strong understanding of EU procedures (DCP, MRP). They should be able to multi-task, communicate effectively with colleagues in global countries, and work independently.
Key Responsibilities:
* Manage EU marketing authorisation dossiers and submissions for pharmaceutical products.
* Prepare and file EU submissions, including life-cycle maintenance variations, initial MAA filling, 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.
* Communicate effectively with European Regulatory Authorities and participate in meetings as needed.
Requirements:
* LIFE SCIENCE QUALIFICATION
* 2-3 YEARS OF EXPERIENCE IN REGULATORY AFFAIRS, PARTICULARLY GOOD KNOWLEDGE OF EU PROCEDURES (DCP, MRP)
* AUTONOMY, MULTI-TASKING ABILITIES
* ABILITY TO COMMUNICATE WITH COLLEAGUES IN GLOBAL COUNTRIES
About the Role:
This is an exciting opportunity for a motivated and experienced Regulatory Affairs Specialist to join our team in Dublin. If you have the skills and qualifications we're looking for, please don't hesitate to apply.