W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9ocm0tcmvjcnvpdg1lbnqvanbnl2pvyi1iyw5uzxiuanbnil1d

Regulatory Affairs Officer

Location: Dublin North, Dublin
Salary: Negotiable
Posted: 3 months ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice, Science Leaders & Specialists
Contact name: Maeve Fahey
Contact email: maeve.fahey@hrmrecruit.com

Job description

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.

W1siziisijiwmtkvmdmvmjavmtivmzcvmjyvnjc1l0qymjq2mi0wmdazlmpwzyjdlfsiccisinrodw1iiiwinteyeduxmimixv0

Maeve Fahey

Science Recruitment Consultant

Current assignments