Director of Regulatory Affairs

The Regulatory Affairs Group is critical for the ongoing support of a wide range of existing products, and the development of new products. The regulatory affairs group consists of a team of skilled professionals working to meet Regulatory, Operational, Business and Scientific objectives.

The Director of Regulatory Affairs is the principal source of regulatory information and advice for the company, in addition to being a working manager, providing guidance to the other regulatory affairs staff, and overseeing the regulatory affairs group. 

The Director  must have strong people management/coaching skills, effective coordination of the entire team, a broad-based knowledge of US and Canadian Regulatory issues, and an ability to work with every group within the organization are critical to the success of the R&D effort and require the skills and talents of highly competent and energetic colleagues.

The Director is a hands-on position that must also be able to synthesize, strategize, plan and coordinate the present and future activities of a diverse team of professionals. The position requires a people oriented person that is experienced, motivated, disciplined, flexible, action-oriented, and results driven. Most suitable would be an effective manager and communicator, and a seasoned problem solver with uncompromising integrity.

Qualifications

• BS/MS, preferably in scientific field (chemistry, biology, animal science, etc.).
• Graduate or professional training a plus.
• Experience in research and regulatory veterinary medicine including interaction with governmental agencies.
• Understanding of the product development process, including establishing development plans protocols, research reports, and reporting.
• Experience in assembling product dossiers for submission to Regulatory Authorities.
• Understanding of regulatory perspectives relative to Chemistry, Manufacturing and Controls (CMC) in a GMP environment.
• Familiarity and experience with pharmaceutical manufacturing.
• Excellent technical writing skills.
• Command of GLP cGMP and GCP concepts.
• Experience with EPA Data Call-in and re-registrations is preferred.
• Experience and/or detailed knowledge of Pharmacovigilance requirements in the US and Canada .

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