Senior Associate US Regulatory Affairs- Advertising Promotion
Senior Associate US Regulatory Affairs- Advertising Promotion
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Job Description
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 inline 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 FDAs 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.
CrossFunctional 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.
Any unsolicited resumes sent to Zoetis from a third party such as an Agency recruiter including unsolicited resumes sent to a Zoetis mailing address fax machine or email address directly to Zoetis employees or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
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 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/careers site or 2 via email to/from addresses using only the Zoetis domain of @zoetis. 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.Required Experience:
Senior IC
Employment Type
Full-Time
