A biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare and orphan diseases, have a growing commercial business and a significant development pipeline. They have a new opportunity within their Regulatory Affairs team for an experienced professional to join on a permanent basis. This role will offer a competitive salary + benefits package, flexible working arrangements and excellent career opportunities.

The Role

Reporting into the Senior Manager Regulatory Affairs, as RA Manager you will be responsible for the implementation of regulatory activities and associated oversight interactions with associated Health Authorities. You will work as part of a growing Global Regulatory team.

The Person

In order to be considered you must have the following:

• A BSc / MSc in Science or related
• 5+ years pharmaceutical experience within Regulatory Affairs
• Experience working with EU and other regions current registration requirements for dossier preparation and procedure running
• EU submission experience essential (Global submissions experience - advantage)
• Project management experience in a regulatory environment

To discover more about this opportunity, apply now or contact Gillian McMurrough at HRM on +353 87 1213548 for a confidential discussion.