Regulatory Affairs Officer

CPL

Waterford

On behalf of our client, a leading pharmaceutical company based in the South-East of Ireland, I am recruiting for a Regulatory Affairs Officer . In this role you will support the Scientific Affairs Department in activities associated with the registration of company products in Worldwide markets including US, EU and Japan, as well as Regulatory compliance liaison with QA for registered products. The role includes regulatory activities associated with both human and veterinary new drug developments as well as generics. The successful candidate will also support activities for running Bioequivalence and Clinical safety and efficacy studies. Responsibilities include: Licence maintenance support to customers, company Regulatory agents and internal departments. Regulatory Compliance liaison with QA. Support licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East. Dossier preparation for submission to all target markets, including liaison with R&D, QC, and Production as well as external experts where required. Strategic planning of regulatory activities in target markets for products. Support activities in the areas of Bio-equivalence and Clinical safety and efficacy study management. Qualifications & Experience: Minimum B.Sc. or a third level qualification required, preferably in Chemistry, Pharmacy or Pharmacology. Previous pharmaceutical experience required; 1-2 years regulatory affairs experience desirable. Familiarity with cGMP in pharmaceutical manufacturing. Familiarity with concepts of Regulatory Approval process for both new drug developments (human and veterinary), and human generic pharmaceutical products. Technical knowledge of analytical/formulation development of pharmaceutical products including solid oral dosage forms, fill finish and inhalations. Working knowledge of Electronic Document Management System. Competent in the use of Microsoft office. For further details and to apply for this role please contact Nicola at +353 1 2784671 or email your CV to ndunphy@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. #THR2018. This job originally appeared on RecruitIreland.com.

1966 days ago