CMC Regulatory Support

Cmc Regulatory Professional

Zoetis means something a little different to every colleague, but at our core, our purpose 'to nurture the world and humankind by advancing care for animals' is what unites us in all our roles.

We are a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than one hundred countries. And we are excited to become a part of the Lithia Springs, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.

We are currently searching for a CMC Regulatory professional to join our team.

Position Summary

CMC Regulatory Support plays a critical role in preparing the Site Master File for the Type V Veterinary Master File (VMF) and developing Outlines of Production for the new GMS Atlanta site, in alignment with FDA and USDA expectations. This role conducts domestic and international regulatory compliance activities for Quality Operations with emphasis on FDA (21 CFR) and USDA/APHIS (9 CFR) regulations, including registration change controls, annual compliance reviews, and project management of Establishment 190 and 190A facility documents.

Position Responsibilities

• 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.

Education and Experience

• 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

Technical Skills and Competencies Required

• 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.

Physical Position Requirements

• Ability to sit, stand, and walk; occasional overtime and weekend work may be required.