Regulatory affairs

Job Description

We are seeking a highly skilled Regulatory Affairs Officer to join our team at Thornshaw Scientific in Dublin.

* Manage EU marketing authorisation dossiers and submissions for our current portfolio of pharmaceutical products, including MAAs, lifecycle activities, variations, transfers, etc.
* Prepare and file the EU submissions, including 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 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 as needed, and follow up on submissions with Health Authorities.


Requirements:

* Life Science qualification.
* 2-3 years of experience in Regulatory Affairs, particularly good knowledge of EU procedures (DCP, MRP).
* Ability to multitask.
* Effective communication with colleagues in global countries.
* Autonomy and multitasking abilities.