Regulatory Affairs Officer

Job title:

Regulatory Affairs Officer

Company

Thornshaw Scientific Recruitment

Job description

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 abilitiesFor full job spec and discussion, email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784701. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com#LI-TD1

Expected salary

Location

Dublin

Job date

Thu, 10 Oct 2024 22:06:29 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsineu.net) you saw this job posting.