Regulatory Affairs Officers - New December 24

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 ****** or call Tina at +353 1 2784701.
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com   #LI-TD1