Job Title:
Regulatory Affairs Officer
Thornshaw Scientific, in collaboration with a global pharmaceutical company, is seeking a highly skilled Regulatory Affairs Officer to join our Dublin team.
Key Responsibilities:
* Manage EU marketing authorisation dossiers and submissions for current pharmaceutical products.
* Prepare and file EU submissions, including life-cycle maintenance variations, initial MAA filling, labelling updates, renewals, and marketing authorisation transfers.
* Write local modules and administrative documents.
* Compile regulatory documentation from other departments for DCP, MRP, and national applications, adhering to assigned timelines.
* Communicate effectively with European Regulatory Authorities and participate in meetings as needed, ensuring timely follow-up on submissions.
Requirements:
* Life Science qualification.
* 2-3 years of experience in Regulatory Affairs, with a strong understanding of EU procedures (DCP, MRP).
* Ability to multitask and communicate with colleagues globally.
* Autonomy and strong multitasking abilities.
This role is an exciting opportunity to join a dynamic team and contribute to the success of our client's pharmaceutical portfolio.
Apply now by submitting your CV, and we will be in touch to discuss this opportunity further.