Senior Associate, US Regulatory Affairs

Senior Associate, Regulatory Affairs

Zoetis is a global animal health company dedicated to supporting customers and their businesses. Building on 60 years of experience, we deliver quality medicines, biopharmaceuticals 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.

Zoetis discovers, develops, and manufactures a diverse portfolio of animal health medicines, biopharmaceuticals and vaccines designed to meet the real-world needs of veterinarians and the livestock farmers and companion animal owners they support.  Zoetis has the first monoclonal antibody therapy for treating atopic dermatitis in dogs.  We are currently seeking to fill a new position to support our regulatory affairs group.

Zoetis Veterinary Medicine Research and Development in Kalamazoo, MI is seeking a Regulatory Affairs Senior Associate.

Responsibilities include, but are not limited to the following:

• Register and maintain state licenses for Zoetis products (e.g., pharmaceuticals, commercial feeds, and pet foods)
• Coordinate creation or revision of labeling materials based on federal regulations for FDA/EPA approved labeling in line with marketing intentions, providing internal review and approval prior to submission
• Manage data collection for required regulatory reports (e.g., CARES)
• Support the maintenance of drug listing and registration.
• Prepare submissions for regulatory agencies.
• Provide support to Regulatory Managers on various projects.

Minimum Qualifications:

• BS/BA in biology, animal science or other related science or equivalent experience. 
• At least 5 years of experience in regulatory affairs for veterinary products, including a minimum of 2 years working directly with state and regional registration and licensing authorities.
• Strong ability to be flexible and adaptable, able to build relationships to successfully work cross-functionally in a complex global environment.

Preferred Skills/ Experience:

• Excellent computer skills
• Strong verbal and written communication skills
• Understanding of the veterinary product development process and FDA-CVM regulatory requirements.
• Ability to work efficiently in a team by organizing, coordinating, and prioritizing work effectively.

Full time

Regular

Colleague

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 [email protected] 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 “@zoetis.com”. 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.