The Manager, Development Projects will design registration and product development operating plans, manage all clinical development aspects of pharmaceutical compounds including design of protocols for product registration studies in the EU and US; including preliminary safety, metabolism, pharmacokinetics and dose titration studies, first efficacy studies in laboratory conditions and pharmacokinetics studies with the final formulation, efficacy studies, safety studies and field trials. The Manager is responsible for negotiations on the clinical program with VMD, EMA, FDA and other relevant regulatory agencies, and will prepare parts III and IV (Safety and Efficacy Technical Sections) of new drug submissions for Veterinary Medicinal Products/New Animal Drugs. The Manager will provide clinical advice and trend analysis for pharmacovigilance reports to relevant regulatory authorities and will follow up on all research and development projects.
Qualifications include experience in research and regulatory veterinary medicine including interaction with governmental agencies, understanding of product development, protocols, Good Clinical Practice guidelines, research reports and dossier preparation. D.V.M, V.M.D, B.V.Sc or equivalent is required.
To learn more and/or apply for this exciting opportunity, please Apply Now.