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Veterinary Diagnostics Regulatory Affairs Specialist

Company: Zoetis, Inc.
Location: Kalamazoo
Posted on: August 13, 2019

Job Description:

POSITION SUMMARY:

Responsibilities include editing and submission of veterinary diagnostic product labels and outlines, and preparation of documents needed for USDA licensing and global marketing authorizations.

JOB DUTIES INCLUDE BUT ARE NOT LIMITED TO:

* Provide regulatory support for US licensing and global expansion.

* Prepare, review, edit, and submit Outlines of Production and provide relevant regulatory guidance to manufacturing and project teams.

* Liaise with project teams, commercial colleagues, manufacturing, and in country regulatory affairs managers to provide editor s copies to the Zoetis artwork center.

* Provide regulatory label guidance specific to USDA and with consideration of global expectations.

* Liaise with USDA for matters related to labels, Outlines and Certificates of Licensing and Inspection.

* Submit requests for Certificates of Free Sale and Apostille in support of global expansion.

* Utilize USDA submissions portal, Zoetis systems and TrackWise for entry and tracking of regulatory activities.

* Facilitate review of risk assessments as needed.

REQUIREMENTS:

* Minimum of BS/BA in science discipline with experience in regulatory affairs.

* Understanding of USDA regulatory requirements.

* Proficiency in MS Office (especially Excel) and similar applications.

* Strong attention to detail, time management.

* Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions.

* Writes clearly and informatively; able to read and interpret written information.

* Identifies and resolves problems in a timely manner.

* Demonstrated ability to work in a team environment.

* Desired: Experience with label revisions, USDA outlines of production, and TrackWise.

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. 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 zoetiscolleagueservices@zoetis.com 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.

Keywords: Zoetis, Inc., Kalamazoo , Veterinary Diagnostics Regulatory Affairs Specialist, Healthcare , Kalamazoo, Michigan

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