We are a pioneering, family-run pharmaceutical company with a laser focus on the development and commercialisation of reproductive hormone treatments for the lifelong well-being of men and women. Our products are used in the fields of gynaecology, fertility, obstetrics, and endocrinology. We distribute to over 90 countries through our own subsidiaries and network of distributors. With approximately 1,300 employees worldwide, 22 subsidiaries and 5 production sites, we continue to grow – something we can only do through recruiting exceptional employees and nurturing an environment where they can thrive.

Description

This position will manage Non-European marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical products.

Your mission:

Prepare and file the Non-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).
Participate in the definition of the regulatory strategy for registration of medicinal products in Non-EU countries. Good overview of registration planning at short-term/middle term.
Effective high-quality communication with European Regulatory Authorities, participate in meetings with health authorities as needed. Follow-up of the submissions with HA.
Communicate about the quantification of workload for each regulatory submission, resource planning and timelines for expected submission & approvals, project finance (regulatory agency fees related to regulatory submissions).

Job Requirements:

Scientific, Pharmaceutical, or Regulatory Affairs degree
1 to 2 years Regulatory Affairs experience
Experience in non-EU markets
Ability to multi-task
Clear and efficient communication skills across topics and regions
Autonomous, good organisational and time management skills
Very good level of English, another language is a plus

Why Join Us in Dublin?

Our Dublin Headquarter hosts diverse cross-functional teams, including Quality, Pharmacovigilance, Medical / Clinical, and Regulatory Affairs. Located in a modern, beautifully designed building in a prime central location, it’s a fantastic place to work and grow. Plus, we offer a flexible hybrid working model, allowing you to balance in-office collaboration with remote work for greater flexibility.

Join us in an exciting, dynamic environment where your contributions will make a real impact.

Are you interested? Don't hesitate to apply !

Besins Healthcare

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