Senior Regulatory Affairs Officer
Senior Regulatory Affairs Officer - County Waterford. Job Purpose: To support the Regulatory Affairs Manager with activities associated with the registration of 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. Mentor and support team members of the regulatory team on designated projects. 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 (human and veterinary; new drugs developments and generics. • CMC Regulatory support to R&D and Clinical Managers for various dosage forms including solid oral dose (tablets, hard capsules, soft gel capsules), fill finish (biologics and small molecules) and inhalations. Minimum Qualifications & Experience required: • Minimum B.Sc. (Bachelor of Science) degree, ideally in discipline of Chemistry, Pharmacy or Pharmacology (but any Science related discipline considered. • Minimum 3 years’ experience in a regulatory affairs role in a pharmaceutical environment. 5 – 8 years' regulatory experience preferable. • Additional experience in pharmaceutical environment – e.g. Quality Control, R&D or Quality Assurance Department advantageous but not essential. Skills & Behavioural Competencies: Familiarity with cGMP in pharmaceutical manufacturing. Significant experience in Global Regulatory Affairs. Technical knowledge of analytical/development of pharmaceutical products. Working knowledge of EDMS (Electronic Document Management System. Competent in the use of Microsoft office. Where applicable, good supervisory skills where the role includes team lead responsibilities. This job originally appeared on RecruitIreland.com.
188 days ago