Opportunities for Regulatory Affairs Officers to join the Dublin team are now available at Thornshaw Scientific, in collaboration with a global pharmaceutical company.
Key Responsibilities:
* Manage EU marketing authorisation dossiers and submissions for our current portfolio of pharmaceutical products.
* Prepare and file the EU submissions including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, and marketing authorisation transfers.
* Write local modules (e.g. module 1) and administrative documents.
* Compile regulatory documentation received from other departments for DCP, MRP, and national applications in line with assigned timelines.
* Effective high-quality communication with European Regulatory Authorities and participate in meetings as needed.
Requirements:
* Lifesciences qualification
* 2-3 years' experience in Regulatory Affairs, particularly good knowledge of EU procedures (DCP, MRP)
* Ability to multitask
* Ability to communicate with colleagues globally
* Autonomy and multitasking abilities