I am delighted to be working with a dynamic, innovative global pharmaceutical company with offices in Dublin City Centre, on a Regulatory Affairs Officer permanent role.
This role will sits within the team responsible for EU Submissions, and you will be responsible for managing European marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical products.
Responsibilities:
- Prepare and file the EU submissions including: life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, marketing authorisation transfers.
- Write the local modules (ex: 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).
- Effective high-quality communication with European Regulatory Authorities, participate in meetings with health authorities as needed. Follow-up of the submissions with HA.
- Communicate about the quantification of workload for each regulatory submission, resource planning and timelines for expected submission & approvals, project finance (regulatory agency fees related to regulatory submissions)
Requirements:
- Scientific, Pharmaceutical, or Regulatory Affairs degree
- 1 to 2 years Regulatory Affairs experience
- Experience in EU markets
- Ability to multi-task
