Senior Regulatory Affairs Specialist - Willmar, MN

About the role:

• Prepare review submit regulatory filings to the USDA CVB including Product License Applications Outlines of Production Special Outlines Summary of Studies supportive data packages.
• Maintain active communication with internal colleagues to facilitate product development approval compliance.
• Support regulatory strategy for both licensed autogenous products initial registration license maintenance Review product labels inserts advertising for compliance with USDA requirements Monitor interpret changes in USDA CVB regulations memoranda guidance documents assess their impact on company operations Assist inspection readiness facility changes audits Support adverse event reporting serial release testing compliance Identify assess deviations potential impacts Collaborate ensure regulatory requirements are understood implemented throughout lifecycle emphasize quality systems Author revise critically review accurate organized regulation documentation SOPs Other duties assigned Qualifications Capabilities Familiarize yourself with 9 CFR Part 113 relevant CVB guidance documents Proven experience preparing submitting regulatory documents Deep understanding USDACVB framework expectations Strong technical writing organizational project management skills Excellent attention detail ability manage multiple priorities Experience autogenous vaccine submissions conditional licensure pathways Analytical critical thinking skills Clear professional communication internal regulators proactive problem-solving work independently Commitment accuracy continuous improvement Proficiency Microsoft Office related applications Bachelor degree biology Microbiology Animal Science Veterinary Science related field Years experience veterinary biologics related US regulated products We are proud provide generous benefit package competitive compensation medical dental vision premiums benefits include Medical Dental Vision Health Savings Account company contribution 401K plan match Paid time accrual Holidays Company paid shutdown days December January Vaxxinova provides wide range vaccines diagnostic services supported strong R D focus livestock cattle poultry swine aqua Vaxxinova US formerly Epitopix Newport Laboratories US operating unit Vaxxinova International headquartered Netherlands USA operating facilities Brazil Canada Chile Colombia Croatia Italy Germany Japan Jordan Norway South Africa Thailand Netherlands EW Group specializes animal genetics nutrition health operates countries records consistent international growth Recruiting Agencies do accept unsolicited CVPromotional Articles from recruiters agencies response job postings social media websites consider agree payment referral recruiter fee relating unsolicited CVPromotional Articles submitted hiring managers deemed property Vaxxinova

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  Job description

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