Director Regulatory Affairs
Director Regulatory Affairs-The Director Regulatory Affairs will devise and execute regulatory strategies for the approval of prescription animal health products, will meet and negotiate with regulatory authorities to plan approval pathways for animal health drugs, advise on the design of pilot and pivotal trials required for approval, respond to queries and correspondence of regulatory authorities. The Director Regulatory Affairs will interpret federal, state, provincial and local laws governing the development and commerce of animal health products working in cooperation of legal counsel as necessary. The incumbent represents the company on industry organizations that interface with regulatory authorities. The incumbent reviews and approves promotional materials for compliance with regulatory requirements. The incumbent identifies and assesses regulatory risks associated with marketing strategies. The incumbent receives, records and pays invoices associated with regulatory fees.
Qualifications include a minimum of 7 years of progressive experience in the Animal Health Industry and regulatory affairs, extensive direct experience meeting with regulatory authorities, e.g., FDA, EMA and Health Canada, comprehensive knowledge of US, Canadian and European regulations pertaining to Animal Health products, excellent written and oral communication skills, degree in veterinary medicine and/or law or life science, Ph.D, preferred.
This is a full time position.
We appreciate the interest from all candidates and will review all applications. We will only be contacting those who best fit the requirements. If you don’t hear from us, we will keep your resume on file for consideration for future searches. This is what you can expect once we have your resume: https://thevetrecruiter.com/working-vet-recruiter/
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