Regulatory Affairs Officer
ICDS Recruitment
Waterford
Regulatory Affairs Officer - County Waterford. Job Purpose: To support the Regulatory Affairs Manager and Senior Regulatory Affairs Officers with activities associated with the registration of the company's 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 new drug developments in both human and veterinary as well as generics. 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 company's products (human and veterinary; solid oral dosage forms, fill finish and inhalations. • Support activities in the areas of Bio-equivalence 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. Skills sought: 1. Familiarity with cGMP in pharmaceutical manufacturing. 2. Familiarity with concepts of Regulatory Approval process for both new drug developments (human and veterinary), and human generic pharmaceutical products. 3. Technical knowledge of analytical/formulation development of pharmaceutical products including solid oral dosage forms (tablets, hard capsules, soft gel capsules), fill finish (biologics and small molecules) and inhalations. 4. Working knowledge of EDMS (Electronic Document Management System. 5. Competent in the use of Microsoft Office. This job originally appeared on RecruitIreland.com.
2262 days ago