Regulatory Affairs & Senior Regulatory Affairs Officer

Thornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The same company also have Senior Regulatory Affairs Officer opportunities.

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 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.

To be considered for this new opportunity you need to meet the following criteria:

• Life Science qualification

• 2-3 years in experience in Regulatory Affairs, in particular good knowledge of EU procedures (DCP, MRP)

• Ability to multi-task

• Ability to communicate with colleagues in global countries

• Autonomy, multi-tasking abilities

For full job spec and discussion, email your CV to or call Tina at 1 . Thornshaw Scientific is a division of the CPL Group