Director of Regulatory Affairs (Field Based Role)
The Director of Regulatory Affairs will lead a team of people as well as will direct the regulatory process for both the US and Canada by ensuring that all necessary documentation is filed and all government interactions are handled appropriately. The Director of Regulatory Affairs will develop processes and procedures to ensure regulatory compliance and will provide sound risk assessments with regards to changes in manufacturing processes. The Director of Regulatory Affairs will be the primary liaison with the FDA’s Center for Veterinary Medicine and will be the subject matter expert for regulatory affairs within the organization. The Director will develop strategies and consult with regulatory agencies for the registration of NADA, ANADA products and equivalent and will collaborate internally by participating on project development teams The Director will provide early guidance on regulatory strategy, labeling and promotional material. The Director will build talent and work with employees on their career development in accordance with the business needs and will educate and broaden the team’s regulatory knowledge through training.
Qualifications include a thorough understanding of regulatory perspectives relative to Chemistry, Manufacturing and Controls (CMC) in a GMP environment, thorough understanding of the product development process, including establishing development strategies, plans, protocols, research reports and reporting and have a strong command of GLP, cGMP and GCP concepts, terminology and definitions. Additional qualifications include demonstrated experience interacting with various regulatory authorities as the primary point of contact. The successful candidate will be able to communicate effectively, have a warm and caring attitude, be able to analyze problems and situations, be able to establish efficient plans, make decisions based on sound judgement, develop cross-functional collaboration and be results oriented. 7-10 years of experience is needed to fulfill the role along with a BS and MS in a scientific field (chemistry, biology, animal science, etc.). Other requirements are experience in research and regulatory veterinary medicine including interaction with governmental agencies, experience with pharmacovigilance requirements in the US and Canada, experience in Pharmaceutical Manufacturing and experience in assembling product dossiers for submission to regulatory authorities.
For immediate consideration for this Animal Health Industry Job Opportunity please apply here:Apply Now