Bachelor's degree in veterinary medicine, Animal Science, Biology, Microbiology, Biotechnology, Regulatory Affairs, or related scientific discipline.
5-8 years of regulatory affairs experience in animal health, veterinary biologics, and vaccines.
Strong experience with USDA CVB and FDA CVM interactions.
Proven track record in preparing and managing USDA regulatory submissions.
Solid understanding of product development and lifecycle management.
Excellent written and verbal communication skills.
Experience with regulatory inspections and compliance activities.
Responsibilities
Provide regulatory guidance to cross-functional teams including R&D, Quality, Manufacturing, and Commercial Operations.
Assess regulatory risks and recommend strategies for timely product development and approvals.
Monitor evolving regulatory requirements and communicate their impact to stakeholders.
Author and implement procedures for compliance with USDA CVB and FDA CVM requirements.
Prepare and manage regulatory filings to USDA CVB, including product licenses and labeling approvals.
Coordinate responses to USDA inquiries and requests for information.
Lead submissions such as INADs, NADAs, and CNADAs, and engage with CVM on technical issues.
Benefits
Health Insurance (Medical, Dental, Vision)
Life and AD&D Insurance
Disability Insurance (LTD & STD)
401k Retirement Plan
Paid Time Off
Full Job Description
Position Summary
The Regulatory Affairs Manager is responsible for supporting the development, registration, approval, and lifecycle management of animal health products. The scope covers veterinary biologics regulated by the USDA Center for Veterinary Biologics (CVB) and FDA Center for Veterinary Medicine (CVM), with a primary focus on products under CVB jurisdiction.
Candidates must have direct hands-on experience working with USDA CVB regulations and submissions for veterinary biologics and vaccines. Experience with FDA human pharmaceutical or biologics regulatory submissions and lifecycle management is highly desirable.
Key Responsibilities
Regulatory Strategy & Compliance
Provide regulatory guidance to cross-functional teams including R&D, Quality, Manufacturing, Technical Services, and Commercial Operations.
Assess regulatory risks and recommend strategies to ensure timely product development and approvals.
Monitor evolving regulatory requirements and communicate their impact to internal stakeholders.
USDA CVB Responsibilities
Author and implement applicable procedures to be in compliance with USDA CVB and FDA CVM requirements.
Prepare, submit and manage regulatory filings to USDA CVB, including:
Product Licenses
Establishment License Document updates
Outline of Production submissions
Labeling approvals
Supplemental and amendment submissions
Permits as needed
Coordinate responses to USDA questions and requests for information.
Lead Inspection readiness for USDA inspections and compliance.
FDA CVM Responsibilities
Lead submissions such as INADs (Investigation New Animal Drug), NADAs (New Animal Drug Application), CNADAs (conditional New Animal Drug Application), and supplement applications.
Engage with CVM on technical, safety, efficacy and manufacturing issues.
Inspection & Audit Support.
Required Qualifications
Bachelor's degree in veterinary medicine, Animal Science, Biology, Microbiology, Biotechnology, Regulatory Affairs, or related scientific discipline.
Minimum 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 with 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.
Preferred Qualifications
Experience supporting FDA-regulated human pharmaceutical and biologic products.
Working knowledge of IND, NDA, BLA, and post-approval regulatory processes.
Working Conditions
Flexible (Hybrid or remote) work options depending on location of the candidate and business needs. No relocation will be provided.
Ability to travel up to 20-30% for agency meetings, inspections, audits, and industry conferences.
Salary (Pay) Range: $100,000 up to $120,000 annually
