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
Benefits:
- Health Insurance (Medical, Dental, Vision)
- Life and AD&D Insurance
- Disability Insurance (LTD & STD)
- 401k Retirement Plan
- Paid Time Off
Why Join Enzene?
At Enzene, we foster a collaborative and innovative environment where science and business intersect. Our team is dedicated to advancing biologics manufacturing through innovation, operational excellence, and a commitment to quality. We offer professional growth opportunities, competitive benefits, and the chance to contribute to life-changing therapies.
Equal Opportunity Employer
Enzene is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace where all employees can thrive.