Our client, a global speciality pharmaceutical company based in North Dublin, is seeking a driven Regulatory Affairs Officer to join the Regulatory team on the generics side of the business.

The Role

Duties and responsibilities of the Reg Affairs Officer will include:

• Managing post-licensing activities - Variations, Renewals and MATs
• Preparing, publishing and maintaining eCTD lifecycles
• Authoring Module 1 documentation
• Reviewing and co-ordination of CMC dossier packages, to support submissions in a number of territories
• Tracking submissions and approval status
• Updating the regulatory database
• Manage change controls for EU and other territories
• Coordinate with various internal and external stakeholders - QA, Manufacturing, Development, Clients etc.

The Person

You will have skills and experience in the following:

• Level 8 degree in a relevant scientific discipline
• 1-3 years of relevant experience in Reg Affairs in a manufacturing environment
• Good knowledge of the relevant EU regulations for the manufacturing of pharmaceutical products
• Knowledge of and experience in FDA regulations is an asset
• Be a self-starter and capable of working autonomously and efficiently
• You are an enthusiastic team worker who gets the job done

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.