My client is a global speciality pharmaceutical company with a portfolio of medicines across a broad range of therapeutic areas in international markets. Due to growth, my client seeks to hire an experienced Regulatory professional to join their team on a permanent basis. The role can be based out of Dublin or home based anywhere in Ireland.
Reporting into the Head of Regulatory Affairs and PV, this role is a new hire for the Irish operation. This role will work in close collaboration with the hiring manager and the successful person will have the opportunity to build the Regulatory Affairs and Pharmacovigilance activities to bring them inhouse, manage Regulatory activities for established products and work on new project introductions and technical transfer projects.
In order to be considered you must have the following:
- A third level qualification in science, engineering or any relevant health science is preferred
- A minimum of 5 years of Pharmaceutical Regulatory Affairs experience
- Substantial first-hand experience of Marketing Authorisation Transfers and Life Cycle Management (LCM) Submissions
- Detailed current knowledge of Centralised EU procedures and regulations (US and Canada experience and exposure in addition to this would be an advantage)
- Previous Pharmacovigilance experience or working knowledge of Drug safety activities - desired but not essential
- Excellent communication and interpersonal skills
- Ability to adapt and have flexibility towards work content as per business needs
- Eligible to live and work in the EU
To discover more about this opportunity, apply now or contact Gillian McMurrough at HRM on +353 871213548 for a confidential discussion.