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.
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.
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.