Regulatory Compliance Leader

Lincoln, Nebraska, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Animal Pharmaceuticals, ManufacturingIndustries

Requirements

Candidates must possess a Biological/Chemistry based degree (B.S. with 14 years, M.S. with 12 years, or DVM/Ph.D. with 9 years) with direct experience in biological or pharmaceutical science development or manufacture. A minimum of five years of management experience, including budget and supervisory responsibilities, and five years of progressive experience in quality assurance, manufacturing, quality control, or regulatory affairs is required.

Responsibilities

The Regulatory Compliance Leader will plan, initiate, and manage policies and procedures for the Regulatory Compliance organization to ensure product compliance with global dossiers and Zoetis Quality Standards. This role includes leading correspondence with US Agencies, managing the Regulatory Compliance team, overseeing product release, investigating customer complaints, managing annual product reviews and the stability program, and ensuring facility documents are current and registrations are maintained. The leader will also manage dossier updates, recalls, market actions, participate in budget planning, and develop performance metrics. Additionally, they will be responsible for staff leadership development, coaching, creating a learning organization, participating in the site's Quality Culture, and ensuring training plans are in place.