Senior Regulatory Affairs Specialist

Vaxxinona US, Inc.•Willmar, MN

2d•$30 - $33•Onsite

About The Position

The Senior Regulatory Affairs Specialist will support the development, licensure, and maintenance of USDA-regulated products. The position will involve ensuring compliance with all applicable regulatory requirements for vaccines and related biological products.

Requirements

Familiar with regulatory agencies including the USDA/CVB, C-CVB, VICH, OSHA, Federal, State, and Local Agencies
Working knowledge of 9 CFR Part 113 and relevant CVB guidance documents.
Deep understanding of USDA CVB regulatory framework and expectations.
Proven experience preparing and submitting regulatory documents to USDA CVB.
Strong technical writing, organizational, and project management skills.
Excellent attention to detail and ability to manage multiple priorities.
Experience with autogenous vaccine submissions and conditional licensure pathways.
Strong analytical and critical thinking skills.
Able to make objective, data driven decisions.
Clear and professional communication with internal teams and regulators.
Proactive problem-solving and ability to work independently.
Commitment to accuracy, compliance, and continuous improvement.
Proficiency in Microsoft Office and related applications
Bachelor’s degree in biology, Microbiology, Animal Science, Veterinary Science, or a related field.
3–7 years of regulatory affairs experience in veterinary biologics or related USDA-regulated products.

Responsibilities

Prepare, review, and submit regulatory filings to the USDA CVB, including: Product License Applications Outlines of Production and Special Outlines Summary of Studies and supportive data packages
Maintain active communication with internal colleagues to facilitate product development, approval, and compliance.
Support regulatory strategy for both licensed and autogenous products, including initial registration and license maintenance.
Review product labels, inserts, and advertising for compliance with USDA requirements.
Monitor and interpret changes in USDA CVB regulations, memoranda, and guidance documents, and assess their impact on company operations.
Assist with inspection readiness, facility changes, and regulatory audits.
Support adverse event reporting, serial release documentation, and testing compliance.
Identify and assess deviations and their potential product and regulatory impacts.
Collaborate with internal departments to ensure regulatory requirements are understood and implemented throughout the product lifecycle with an emphasis on quality systems.
Author, revise and critically review accurate, well-organized regulatory documentation and SOPs.
Other duties as assigned.

Benefits

Medical
Dental
Vision
Health Savings Account with company contribution
401K plan with company match
Paid time off accrual
9 Paid holidays
Company paid shutdown consisting of 4 business days between December 25 and December 31
Company paid short and long-term disability
Company paid life insurance
And many other voluntary benefits