Senior Associate, US Regulatory Affairs- Advertising & Promotion

Senior Associate, US Regulatory Affairs - Advertising & Promotion

The Senior Associate assists in providing regulatory guidance and review of Biological and Pharmaceutical Advertising and Promotional (A&P) initiatives and materials working with US Operations colleagues and assists in providing support in the defense of in-line products from competitive challenges. The Senior Associate assists in preparation for any interface between Zoetis and the USDA Center for Veterinary Biologics (CVB) and the FDA's Center for Veterinary Medicine (CVM) for A&P compliance. The Senior Associate is responsible, when appropriate, for managing and coordinating regulatory activities associated with filing of A&P materials to the USDA/CVB and FDA/CVM.

Responsibilities

Review Promotional Materials

*Assist in the review of A&P materials (e.g., brochures, digital ads, social media posts, websites, sales aids) to ensure compliance with FDA and USDA regulations, including 21 CFR Part 202, 9 CFR, and other applicable guidelines.

Regulatory Compliance

*Ensure that promotional content adheres to regulatory standards, including fair balance, avoidance of misleading claims, and proper presentation of risk information.

*Collaborate with senior reviewers to identify and address compliance issues.

Cross-Functional Collaboration

*Collaborate with Legal, Corporate Communications, Global Commercial Development, U.S. Operations, Business Technology, 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.

*Prepare FDA product A&P materials for submission to FDA. Work with commercial teams and regulatory submission publishing teams to coordinate submission.

Training and Development

*Stay updated on changes to FDA regulations and industry best practices related to advertising and promotion.

*Assist in training across Zoetis regarding actions of USDA/CVB and FDA/CVM that may impact U.S. Operations business opportunities.

Skills, education, experience, attributes

• BS/MS with 3 to 5 years of experience in a scientific discipline. Specifically, Animal Health biologicals and/or pharmaceuticals Advertising and Promotion regulatory review is desirable.
• Experience in the animal health product industry with a strong scientific background in biological and pharmaceutical products is desirable. Understanding of the 9 and 21 Code of Federal Regulations for animal products for advertising and promotion materials is desired.
• Ability to interpret regulations and to leverage them into favorable strategies for promotion of biological and pharmaceutical 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. Experience with Veeva Vault is desirable.
  

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

Diversity, Equity & Inclusion

Connected to our purpose and Core Beliefs, at Zoetis, we lead with inclusion. Our Diversity, Equity & Inclusion (DE&I) focus helps create an environment where each colleague can thrive. Our commitment to DE&I begins with our leadership team of diverse backgrounds, experiences and ethnicities, and it is demonstrated in our support of our colleagues and the animal health industry. We have nine colleague resources groups whose members spread awareness, foster inclusivity and make a positive impact on our business and communities.

Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a 2024 Catalyst Award recipient and a Top 50 Company for Workplace Fairness by Fair360 (formerly DiversityInc). Zoetis has also been named a Best Place to Work for LGBTQ+ Equality, a Best Company for Working Parents, a Top Company for Executive Women, among many others. Learn more here.

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