Regulatory Affairs Officer
We are seeking a highly skilled Regulatory Affairs Officer to join our Dublin team.
Key Responsibilities:
* Manage EU marketing authorisation dossiers and submissions, including lifecycle activities, variations, and transfers for our 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 from other departments for DCP, MRP, and national applications.
Requirements:
* Life Science qualification.
* 2-3 years of experience in Regulatory Affairs, with a strong knowledge of EU procedures (DCP, MRP).
* Ability to multitask and communicate effectively with colleagues in global countries.
* Autonomy and multi-tasking abilities.