Manager, Regulatory Compliance

States considered:

Zoetis is the world’s largest Manufacturer and Supplier of Animal Pharmaceuticals.

At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska’s Safest Companies, with a long-standing presence in Lincoln and we continue to grow.

Benefits Include:

$500 sign on bonus!

Great Health Benefits from day 1!

4 weeks accrued paid vacation and 13 paid holidays

401(k) match with company profit sharing

Tuition reimbursement

Position Summary

Manage US domestic and international regulatory compliance activities for Lincoln Operations with emphasis on USDA, DEA and FDA activities, registration change controls (including defending technical data to country authorities), serial variations, market actions/recalls, artwork review and approval and annual compliance reviews (Outlines of Production & Administrative Audit). This position serves as the principle back-up to the Primary Liaison for the USDA Center of Veterinary Biologics Inspection & Compliance.

Position Responsibilities

Manage the completion of the following responsibilities:

• Manage all site DEA registrations. Ensure all regulatory requirements are met.
• Serve as a key Zoetis Establishment 190 representative to USDA & international regulatory colleagues and agencies regarding compliance and registration support activities.
• Perform, review, and approve investigations into biological product complaints to ensure products released in the market are safe, pure, potent, and efficacious. Perform periodic trending of complaints and identify opportunities for product improvements to eliminate product defects. Ensure investigations meet the requirements and expectations of the relevant regulatory authority. Present periodic trends to LSQC.
• Manage pharmaceutical and biological registration change control, including the annual outline of production review, QQFs and RCR/SARs.
• Support/assist with miscellaneous regulatory support functions such as the annual administrative inspection review, market actions/recalls, periodic blueprint & legend updates and artwork review and approval.
• Assess and determine need for regulatory notifications. Defend registration process deviations (variations) to USDA and other appropriate regulatory agencies.
• Monitor regulatory communications and ensure that any commitments to the agencies are endorsed by leadership and communicated. Ensure commitments are met and/or communicate progress to the regulatory authority.
• Maintain a thorough knowledge of USDA, FDA and DEA regulatory requirements associated with the testing and manufacturing of veterinary products.
• Advise management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
• Participate in industry and trade association committees to align Zoetis Quality Standards, government regulations, and the quality needs of Animal Health customers.

Organizational Relationships

• Interact with Manufacturing, QA, QC, VMRD, Pharmacovigilance and VMIPS.
• Interface and interact with other USDA Establishment License 190 Facilities.

Education and Experience

• D.V.M. and/or Ph.D. with 5 years, M.S. with 7 years, B.S. with 10 years or equivalent in biological or pharmaceutical sciences, or related discipline.

Technical Skills and Competencies Required

Minimum Qualifications:

• In-depth knowledge of USDA, DEA, and FDA regulatory requirements for an international veterinary biological/pharmaceutical manufacturing site.
• Excellent written, oral, and interpersonal skills and ability to work in a team environment
• Demonstrated ability to perform and reach targeted conclusions.
• Ability to establish appropriate timelines to meet project milestones and timelines.
• Process and detail oriented with the ability to review and/or prepare detailed structured documents.
• Ability to develop solutions to routine and complex problems.
• Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work.
• Ability to communicate effectively with Team Members to facilitate completion of required investigation activities to meet all deadlines.

Preferred Qualifications:

• Demonstrated experience in the ability to influence and negotiate with external regulators.
• Demonstrated experience performing and/or approving investigations into deviations and/or product complaints.
• Demonstrated knowledge of the deviation, change control, laboratory information management and manufacturing systems.

Physical Position Requirements

• This position requires sitting, standing, and walking with occasional overtime/weekend work.
• Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas.

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 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.

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