Manager, Veterinary Diagnostics Regulatory Affairs
Provide regulatory expertise, support and guidance to the Zoetis research and development (R&D) project teams and manufacturing facilities in support of pre-license and on-market products. To support globally marketed products, the scope will include consumables for both infectious and non-infectious disease and, when applicable, instruments. This individual will provide strategy and advice regarding data and documentation to ensure regulatory approval and maintenance of veterinary diagnostic products. The primary focus will relate to USDA regulated veterinary diagnostic products.
Full time, position based in Kalamazoo, MI.
JOB DUTIES include but are not limited to:
- Develop regulatory strategy and offer regulatory solutions as member of cross-functional, multi-site, Diagnostic Product Discovery and Development Teams.
- Author USDA submissions and contribute to globally compliant diagnostic regulatory dossiers.
- Supply regulatory advice to USDA manufacturing sites regarding replacement of reagents and serial release panels and transfer of assay from R&D or other sites.
- Serve as alternate USDA Liaison.
- Assess regulatory options for post-market initiatives and market enhancements.
- Provide regulatory guidance to the diagnostic label team for new product or updated labels.
- Educate and train others on Global Regulatory Systems, Processes, and Procedures as applicable.
- Contribute to risk mitigation, assessments and due diligence when applicable.
- Communicate, own deliverables and embrace priorities that align with the needs of Zoetis stakeholders and partner groups
- Degree in biological, animal science, or veterinary medicine or a related discipline.
- PhD or DVM preferred.
- Regulatory Affairs experience associated with the products regulated by the USDA.
- Diagnostic specific background preferred.
- Knowledge in the development, production and testing of veterinary diagnostic products desirable.
- Strong verbal and written communication, negotiation and organizational skills.
- High level of competency using Microsoft Office suite, Microsoft Word and Excel.
- Able to effectively communicate in English with colleagues at all levels of the organization and external regulatory agencies.
- Attention to detail to ensure all expectations of submissions to external agencies are met.
- Ability to develop and implement sound and creative solutions to regulatory issues.
- Flexibility and capacity to handle multiple tasks at once.
- Demonstration of a highly effective and deeply committed team player.
- Consistently models behaviors of accountability, approachability, and ownership.
- Ability to work independently, while fostering good working relationships across physical distance.
- Capable of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment.
- He/she will influence without authority and support colleagues outside of the regulatory team as the need arises.
- Passionate and Enthusiastic
- Actions inspires colleagues and demonstrate “can do” energy and follow through.