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.
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 [email protected] or call Tina or Linda at +353 1 2784701. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
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