Manager, Regulatory Compliance at Zoetis

Lincoln, Nebraska, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Veterinary, Animal HealthIndustries

Requirements

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

Responsibilities

Manage all site DEA registrations and 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; ensure investigations meet regulatory authority requirements; 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
Interact with Manufacturing, QA, QC, VMRD, Pharmacovigilance, and VMIPS; interface and interact with other USDA Establishment License 190 Facilities