Manager I US Biologics Regulatory Affairs
Manager I US Biologics Regulatory Affairs
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Salary Not Disclosed
1 Vacancy
Job Description
States considered: Michigan
Role Description
The position will address veterinary biological product registration needs for the United States. Candidate will be responsible for ensuring that biological including biopharmaceutical products are developed registered and maintained in compliance with USDA Center for Veterinary Biologics regulatory requirements. Candidate will liaise closely with other US biologics regulatory staff to facilitate US registrations consistent with the company portfolio plan. Candidate will also connect with international regulatory staff to facilitate global registration where appropriate. Candidate will represent regulatory affairs on project teams with the responsibility to align with partner groups and organizations to drive product registrations consistent with approved product profiles.
Position Responsibilities
- Serve as member on multidisciplinary project teams responsible for developing veterinary biological and biopharmaceutical products develop the regulatory strategy for the team and be responsible for all US regulatory submissions for that project with high level of autonomy.
- Serve as an advisor in early lead seeking and research phase projects to provide timely regulatory input and direction.
- Liaise with Global Commercial Development and Global Biologics teams to develop and negotiate label claims and product supporting materials.
- Liaise closely in the regions to facilitate global registration where appropriate.
- Provide regulatory support and advice regarding Global Manufacturing and Supply initiatives and market enhancements.
- Provide regulatory support of biological product labeling advertisement and promotional materials.
- Provide regulatory support to internal regulatory group processes and systems when needed for unlicensed and licensed products.
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.
- Being comfortable with standard software (Excel etc. and communication technologies.
- Position will be on site Kalamazoo MI or remote.
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 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:
Manager
Employment Type
Full-Time
