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(Archived) Manager, US Regulatory Affairs - Post-Approval

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Last Updated: 3/03/21

Job Description

Job Description

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.

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 policies.

  • Provide up to date training materials on US regulations for advertising and promotion and company policies to all relevant US colleagues.

Zoetis expectations

  • 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.

Full time

Regular

Colleague

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [Register to View] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of [Register to View] In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Regulatory Affairs

Regulatory Affairs Director

No

Kalamazoo, Michigan, United States

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Company Details

Zoetis
Parsippany, New Jersey, United States
Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.