Manager, US Regulatory Affairs - Post-Approval
The Regulatory Manager provides regulatory guidance, strategic direction, and review of Biological and Pharmaceutical advertising and promotional materials and provides support in the defense of in-line products from competitive challenges. The Regulatory Manager additionally acts as interface between Zoetis and the USDA Center for Veterinary Biologics (CVB) and the FDA’s Center for Veterinary Medicine (CVM) for post-approval labeling activities.
Provide timely and thorough feedback to U.S. operations regarding business initiatives, including but not limited to advertising and promotion, product launch plans, product profile/positioning development to ensure compliance with applicable US regulations and Zoetis policies.
Provide up to date training materials on US regulations for advertising and promotion and company policies to all relevant US colleagues.
Collaborate with Legal, Corporate Communications, Global Commercial Development and Lifecycle Management, U.S. Operations, Business Technology, and Veterinary Medicine Research & Development colleagues to ensure that promotional boundaries and possibilities of product profile messaging are understood within the framework of current USDA/CVB and FDA/CVM interpretation and enforcement.
Provide organizational training and updates across Zoetis regarding actions of USDA/CVB and FDA/CVM that might impact U.S. Operations business opportunities.
Respond to queries and issues from USDA/CVB and FDA/CVM associated with Advertising and Promotional materials.
Provide leadership and advocacy for US Operations for commercialization strategies and competitive activities with trade associations and government agencies.
Up to 25% travel
Skills, education, experience, attributes:
DVM and/or PhD with 3 to 5 years of experience or BS/MS with 5 to 10 years of experience in the animal health industry.
Previous experience in regulatory review of advertising and promotion in the animal health industry. Strong documentation, writing, teaching and oral communication skills.
Understanding of the 21 CFR Part 202 drug advertising and promotion regulations, the
9 CFR Code of Federal Regulations for animal products, and Memorandum No. 800.98 for advertising and promotion materials.
Ability to interpret regulations and to leverage them into favorable strategies for promotion of veterinary products and compliance.
Proven interpersonal/communication skills are essential, as these are required to influence positive outcomes with regulators and colleagues on teams.
Fully versed in Microsoft Office platforms, including Word, Outlook and PowerPoint.