CMC Regulatory Support

What is it like to work for Zoetis, the world leader in animal health? 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.

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.