Senior Regulatory Affairs Specialist

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Willmar, MN, US

30+ days ago Requisition

Salary Range: $30.00 To $33.00 Hourly

This position will be in our office in Willmar, Minnesota or Worthington, Minnesota.

The starting pay range will be $30-$33 per hour, depending on experience.

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.

Main 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.

Qualifications and Capabilities:

• 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

Experience/

Educational Requirements:

• 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.

Benefits at Vaxxinova:

We are proud to offer a generous benefit package in addition to competitive compensation, including employer contributions towards medical, dental and vision premiums. Most benefits begin on date of hire. Our benefits include:

• Medical
• 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 25and December 31
• Company paid short and long-term disability
• And many other voluntary benefits