Manager/Associate Director – Biological Regulatory Affairs
Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.Our name, Zoetis (z-EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning “pertaining to life.” It signals our company”s dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend.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.The position will address veterinary biological product registration needs for the United States. Candidate will be responsible for ensuring that biological products are developed, registered, and maintained in compliance with USDA CVB regulatory requirements. Candidate will liaise closely with other US regulatory staff to facilitate US registrations consistent with the company portfolio plan. Candidate will also liaise with international regulatory staff to facilitate global registration where appropriate. Candidate will represent Regulatory Affairs (VMRA) on project teams with the responsibility to liaise with Laboratory Sciences, Global Development and Operations, Commercial Development, Global Biological Research, Manufacturing and other partner groups to drive product registrations consistent with approved product profiles.
1. Serve as member on multidisciplinary Project Teams responsible for developing veterinary biological products,
develop the regulatory strategy for the team, and be responsible for all US regulatory submissions for that project with
minimum supervision from the Director or Senior Director.
2. Serve as a liaison with Biological Discovery to provide early regulatory input into early phase Discovery projects. 3. Liaise with Commercial Development-Lifecylce Innovation and the Therapeutic Areas to conduct BOAs and BioScans, and to develop label claims and product
supporting materials. 4. Responsible for Production Outlines, Special Outlines and required supporting documentation.
5. Liaise closely in the regions to facilitate global registration where appropriate. 6. Serve as an alternate Liaison with USDA. 7. Provide regulatory support for reference re-qualification. 8. Provide regulatory support and advice regarding GMS initiatives and market enhancements. 9. Provide regulatory support of biological advertisement and promotional materials.
EDUCATION AND EXPERIENCE
* MS in biology, animal science or other related science. * PhD or DVM desirable. * A minimum of 5 years” experience with veterinary biological products, preferably in regulatory affairs or a related area. * Veterinary clinical experience will also be considered.
TECHNICAL SKILLS REQUIREMENTS * Strong verbal and written communication skills, and a demonstrated ability to work in a team environment. * Understanding of the veterinary biological development process and USDA regulatory requirements desirable.
* Knowledge in the production and testing of veterinary biological products desirable. 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. 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.