Regulatory Affairs Officer Job In Dublin

Regulatory Affairs Officer sought to manage EU marketing authorisation dossiers and submissions for pharmaceutical products, ensuring compliance with EU procedures and regulations.

Thornshaw Scientific, a division of the CPL Group, collaborates with a global pharmaceutical company to deliver high-quality regulatory services.

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.

Requirements:

• 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