Regulatory Affairs Officer
We are seeking a skilled Regulatory Affairs Officer to join our Dublin team. As part of this role, you will be responsible for managing EU marketing authorisation dossiers and submissions for our pharmaceutical products.
Key Responsibilities:
* Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical products.
* Prepare and file the EU submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, marketing authorisation transfers.
* Write local modules (e.g. module 1) and administrative documents.
* Compile regulatory documentation received from other departments (CMC, clinical) for DCP, MRP and national applications in line with assigned timelines (including responses to questions).
* Communicate effectively with European Regulatory Authorities, participate in meetings as needed and follow-up on submissions.
Requirements:
* Life Science qualification.
* 2-3 years of experience in Regulatory Affairs, with good knowledge of EU procedures (DCP, MRP).
* Ability to multi-task and communicate with colleagues globally.
* Autonomy and strong multi-tasking abilities.