Regulatory Affairs Officer
Regulatory Affairs Officer - County Waterford. Job Purpose: To support the Scientific Affairs Department in activities associated with the registration of 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. To support activities for running Bioequivalence and Clinical safety and efficacy studies. Key Responsibilities: Licence maintenance support to customers, 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 Bioequivalence and Clinical safety and efficacy study management. Minimum Qualifications & Experience sought: 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. This job originally appeared on RecruitIreland.com.
141 days ago