Manager – Regulatory Affairs

The position is responsible for coordinating quality regulatory submissions to the United States Department of Agriculture’s (USDA), specifically The Center of Veterinary Biologics (CVB), in order to meet company’s overall strategic and business objectives as products must first be licensed in the USA prior to licensing/marketing globally.

By combining their knowledge of scientific, legal and business issues, the incumbent insures the appropriate licensing strategy in order to license the veterinary biological product in the most expedient time. The person monitors regulations, both domestic and abroad, to ensure registration maintenance, compliance and product life cycle management guidelines are maintained and monitors and update changes to regulations to determine possible impacts on products. The position also ensures compliance for pharmacovigilance (adverse event processing and safety report submissions) to comply with US regulations.

QUALIFICATONS:

Education: M.S. in biology, or related life/medical science field and 5-7 years of direct Regulatory Experience or B.S. in biology, or related life/medical science field and 7-10 years of direct Regulatory Experience. Degree in Veterinary Medicine (DVM) preferred.

Work Experience: A minimum of five years experience in product registration is required. Incumbent needs to have knowledge and experience with The Center of Veterinary Biologics (USDA – 9 CFR), and working knowledge of the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA) and other Regulatory Agencies (Canada, China, Japan, Asia Pacific, and Latin America).

Skills: Strong interpersonal and communications skills, and organizational and planning abilities needed to handle multiple tasks concurrently. Good computer (spreadsheet and database) skills.  

May require up to 20% travel (local, regional or international).

To learn more about this exciting opportunity, please  Apply Now.