CMC Regulatory Support

Role Overview

• 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.

Tech Stack

• Vault

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.