Regulatory Affairs Manager

Manager, US 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 our client`s overall strategic and business objectives as products must be first 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.

Qualifications include: USDA regulatory affairs experience, veterinary biologics approval experience, experience running & conducting clinical studies.

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