Regulatory affairs officer (x 2 positions)
Teva Pharmaceuticals Ireland is part of Teva Pharmaceutical Industries Ltd, the world's leading generic pharmaceutical company and a top 10 global pharmaceutical company. Teva is the largest volume supplier of medicines to Irish patients, and is a major employer in Ireland, with more than 500 highly-skilled staff working in both the company's Waterford-based manufacturing facility and the commercial office, based in Dundalk.
Due to recent expansion of the business, two positions (1 x permanent, 1 x temporary 12 month contract) have arisen in the Dundalk office in the regulatory affairs department. The purpose of the roles is to support the regulatory affairs department in the maintenance of product licences in Ireland and Malta. Key tasks include:
- Liaising with regulatory authorities in relation to new product applications
- Liaising with customers, sales representatives, medical, quality, pharmacovigilance, logistics, and with members of the Teva group of companies based elsewhere in Europe/worldwide
- Preparation, compilation, review and submission of variations and renewals
- Ensuring ongoing regulatory compliance of products (e.g. maintaining up-to-date product information, packaging artwork, databases etc.)
- Contributing to compliance of the commercial business with relevant regulatory and corporate requirements.
The successful candidate will demonstrate the following skills and knowledge:
- Third level qualification to Degree standard in any area of life sciences
- Excellent written and verbal communication skills
- Excellent organisation and planning skills
- Particular attention to detail including adherence to deadlines
- PC application skills
- Experience in the pharmaceutical industry/regulatory affairs is desirable but not essential.
Please send applications by email to
(attaching a C.V.), or apply in writing to:
Associate Director Regulatory Affairs
Teva Pharmaceuticals Ireland
Building B, Xerox Technology Park
Closing date for receipt of applications: 31 October 2017.