Senior Regulatory Affairs Specialist

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.

About the role:

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
• 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

About Vaxxinova

Vaxxinova provides a wide range of both autogenous and licensed vaccines combined with high-level diagnostic services, supported by strong R&D. Our focus is on livestock including cattle, poultry, swine and aqua. Vaxxinova US, formerly known as Epitopix and Newport Laboratories, is the US operating unit of Vaxxinova International, headquartered in the Netherlands. Vaxxinova US has a strong market presence making autogenous vaccines for cattle, swine, and poultry as well as a state-of-the-art diagnostic laboratory. Vaxxinova currently has facilities in fourteen countries including Brazil, Canada, Chile, Colombia, Croatia, Italy, Germany, Japan, Jordan, Norway, South Africa, Thailand, the USA, and the Netherlands. Vaxxinova is part of the family-owned EW Group, headquartered in Germany. The EW Group specializes in animal genetics, animal nutrition and animal health, operates in over 100 countries and records consistent international growth.

Recruiting Agencies

Vaxxinova US does not accept unsolicited CVs from recruiters or employment agencies in response to job postings on social media or Vaxxinova US websites. Vaxxinova US will not consider or agree to payment of any referral compensation or recruiter fee relating to these unsolicited CVs. Vaxxinova US explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited CVs, including those submitted to hiring managers, are deemed to be the property of Vaxxinova US. Phone calls or emails from recruiters or employment agencies are not appreciated.