Manager, US Regulatory Affairs- Advertising & Promotion

Zoetis • Kalamazoo, MI

22d

About The Position

Manager, US Regulatory Affairs - Advertising & Promotion The Manager provides regulatory guidance, strategic direction, and review of Biological and Pharmaceutical Advertising and Promotional initiatives and materials working with US Operations colleagues and provides support of the Operation in the defense of in-line products from competitive challenges. The Manager acts as interface between Zoetis and the USDA Center for Veterinary Biologics (CVB) and the FDA’s Center for Veterinary Medicine (CVM) for Advertising and Promotional compliance and is responsible, when appropriate, for managing and coordinating regulatory activities associated with filing of Advertising and Promotional materials to the CVB and CVM.

Requirements

• BS/MS with 3 to 5 years of experience in Animal Health Biologicals and/or pharmaceuticals Advertising and Promotion regulatory review.
• Experience in the animal health product industry with a strong scientific background and broad understanding of animal health drug product development.
• Understanding of 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 and compliance.
• Proven interpersonal/communication skills are essential, as these are required for positive interactions with external and internal agencies and teams.
• Fully versed in Microsoft Office platforms, including Word, Outlook and PowerPoint.

Nice To Haves

• PhD or DVM desirable.
• Experience with Veeva Vault Platform is highly desirable.

Responsibilities

• 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 expectations.
• Collaborate with Legal, Corporate Communications, Global Commercial Development, U.S. Operations, and VMRD 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.
• Prepare FDA product A&P materials for submission to FDA.
• Work with commercial teams and regulatory submission publishing teams to coordinate submission.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees