Regulatory Affairs Officer Opportunity at CPL Group
About the Role
We are collaborating with a global pharmaceutical company to fill a Regulatory Affairs Officer position in our Dublin team.
Key Responsibilities:
* Manage EU marketing authorisation dossiers and submissions for pharmaceutical products, including lifecycle activities, variations, transfers, MAAs, and more.
* Prepare and file EU submissions, such as life-cycle maintenance variations, initial MAA filings, labelling updates, renewals, and marketing authorisation transfers.
* Write local modules (e.g., module 1) and administrative documents.
* Compile regulatory documentation from other departments (CMC, clinical) for DCP, MRP, and national applications, meeting assigned timelines and responding to questions.
* Effectively communicate with European Regulatory Authorities, participate in health authority meetings, and follow up on submissions.
Requirements
* Life Science qualification
* 2-3 years of experience in Regulatory Affairs, particularly in EU procedures (DCP, MRP)
* Ability to multitask
* Effective communication with colleagues in global countries
* Autonomy and multitasking abilities