Regulatory Affairs Manager/Senior Manager
About The Position
The Regulatory Affairs Manager supports the development, registration, approval, and lifecycle management of animal health products, including veterinary biologics regulated by the USDA Center for Veterinary Biologics (CVB) and the FDA Center for Veterinary Medicine (CVM), with a primary focus on products under CVB jurisdiction. Direct hands-on experience with USDA CVB regulations and submissions for veterinary biologics and vaccines is required. Experience with FDA human pharmaceutical or biologics regulatory submissions and lifecycle management is highly desirable. The role provides regulatory guidance to cross-functional teams, assesses regulatory risks, monitors regulatory requirements, and manages submissions and agency interactions. It also supports inspection readiness and compliance. The position offers flexible hybrid or remote work options depending on the candidate’s location and business needs. Travel of up to 20–30% may be required for agency meetings, inspections, audits, and industry conferences. No relocation will be provided.
Requirements
- Bachelor’s degree in veterinary medicine, Animal Science, Biology, Microbiology, Biotechnology, Regulatory Affairs, or a related scientific discipline.
- 5–8 years of regulatory affairs experience within animal health, veterinary biologics, and vaccines.
- Strong experience interacting with USDA Center for Veterinary Biologics (CVB) and FDA Center for Veterinary Medicine (CVM).
- Demonstrated experience preparing and managing USDA regulatory submissions.
- Strong understanding of product development, regulatory submissions, approvals, and lifecycle management.
- Experience interacting directly with regulatory agencies and managing regulatory correspondence.
- Excellent written and verbal communication skills.
- Experience supporting regulatory inspections and compliance activities.
Nice To Haves
- Experience supporting FDA-regulated human pharmaceutical and biologic products.
- Working knowledge of IND, NDA, BLA, and post-approval regulatory processes.
Responsibilities
- Provide regulatory guidance to R&D, Quality, Manufacturing, Technical Services, and Commercial Operations.
- Assess regulatory risks and recommend strategies to support timely product development and approvals.
- Monitor evolving regulatory requirements and communicate their impact to internal stakeholders.
- Author and implement procedures to comply with USDA CVB and FDA CVM requirements.
- Prepare, submit, and manage USDA CVB filings, including product licenses, establishment license document updates, outlines of production, labeling approvals, supplemental and amendment submissions, and permits as needed.
- Coordinate responses to USDA questions and requests for information.
- Lead readiness for USDA inspections and support compliance.
- Lead FDA CVM submissions, including INADs, NADAs, CNADAs, and supplemental applications.
- Engage with FDA CVM on technical, safety, efficacy, and manufacturing issues.
- Support inspections and audits.
Benefits
- Health insurance, including medical, dental, and vision.
- Life and AD&D insurance.
- Long-term and short-term disability insurance.
- 401(k) retirement plan.
- Paid time off.
- Professional growth opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
