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

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