Zoetis

CMC Regulatory Support

Zoetis

full-time

Posted on:

Location Type: Office

Location: Lithia Springs • United States

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Tech Stack

Vault

About the role

  • Maintain thorough knowledge of FDA/APHIS/USDA/EU regulatory requirements for the testing and manufacture of veterinary biological and pharmaceutical products.
  • Manage biological registration change control, including annual Outline of Production review and updates; prepare and submit regulatory change requests and submission action requests; coordinate regulatory communications and manage revisions.
  • Support annual administrative inspection readiness and reviews; coordinate market actions and recalls in compliance with 21 CFR and 9 CFR requirements.
  • Manage GMS facility documents (e.g., blueprints, legends) to ensure accuracy, control, and audit readiness.
  • Collect and analyze data for Annual Product Reviews (biopharmaceutical and biological products), including trending of market actions, rework, recalls, and regulatory notifications to USDA.
  • Participate on cross-functional teams to address quality issues and drive project improvements.
  • Advise management on regulatory deficiencies and recommend actions when products or processes do not meet GMS or regulatory requirements.
  • Ensure all Outlines of Production comply with contemporary USDA standards, including 9 CFR 114 and VSM 800.206.
  • Interpret and apply 9 CFR, 21 CFR, EU, and other relevant regulatory guidelines; support consistent enforcement through procedures and training.
  • Support regulatory agency, customer, and internal audits, including preparation, hosting, and response activities.
  • Participate in change management activities (e.g., impact assessments, documentation updates, approvals).
  • Maintain department Standard Operating Procedures (SOPs) to ensure compliance, clarity, and alignment with current regulations.
  • Perform other responsibilities as assigned.

Requirements

  • Bachelor’s degree or equivalent in an industry related field
  • 5 – 7 years of experience in Quality or manufacturing, 7+ years preferred
  • Minimum 3 years of relevant regulatory experience, experience in both FDA (21 CFR) and USDA/APHIS (9 CFR) regulated environment preferred
  • Demonstrated ability to write and review technical documents with high attention to detail.
  • Ability to establish timelines and meet project milestones with minimal supervision.
  • High integrity and self-motivation.
  • Proven project management and organizational skills.
  • Ability to develop solutions to routine problems by following established procedures.
  • Strong organizational and administrative skills; proven ability to multitask and prioritize in support of standard work.
  • Strong oral and written communication skills; ability to effectively engage team members to facilitate requests, reviews, and approvals.
  • Demonstrated ability to identify issues and escalate appropriately.
  • Thorough knowledge of FDA/USDA/EU regulatory requirements for testing and manufacturing of veterinary biological and pharmaceutical products.
  • Demonstrated ability to work effectively with internal and external stakeholders.
  • Proficiency with MS Word, Excel, Outlook, TrackWise, LIMS, Veeva Vault, and SAP.
Benefits
  • Competitive healthcare and retirement savings benefits
  • An array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory compliancedata analysistechnical writingproject managementchange managementquality assurancedocument controlaudit preparationSOP developmentbiopharmaceutical manufacturing
Soft Skills
attention to detailself-motivationorganizational skillsmultitaskingprioritizationoral communicationwritten communicationproblem-solvingstakeholder engagementteam collaboration