Regulatory Affairs Specialist

1 week ago

Overland Park, KS, United States Kemin Full time
Overview

Hennessy Research Associates - a Kemin Company is hiring a Regulatory Affairs Specialist.

We're looking for someone who thrives in a fast-paced, collaborative environment-someone who's not afraid to jump in, learn on the fly, and tackle new challenges with enthusiasm. If you're adaptable, curious, and ready to make an impact, this is your chance to shine. Bonus points if you've got a knack for writing, editing and reviewing scientific documentation. This isn't just a job-it's a launchpad for growth, innovation, and making a real difference. This role will put you in the midst of licensing new products for veterinary use.

This is an excellent opportunity for a regulatory professional who is passionate about animal health and enjoys working in a fast-paced, science-driven environment.

This position is based on-site at our Lenexa, Kansas location.

Join the Kemin Team and Transform Lives

We are a privately held, family-owned-and-operated global biotechnology company driven by curiosity and committed to transforming the quality of life for people, pets, and the planet.

We create solutions that strengthen health and wellbeing, provide nutrition and immune support for pets and production animals, safeguard the planet's natural resources, and protect the global food supply chain for generations to come.

We supply over 500 specialty ingredients for various industries, including human and animal health and nutrition, pet food, aquaculture, nutraceutical, food technologies, crop technologies, textiles, biofuels, and animal vaccines.

We employ 3,500 global employees and operations in 90 countries, including manufacturing facilities in Belgium, Brazil, China, Egypt, India, Italy, San Marino, Singapore, South Africa, and the United States.

As a valued member of our team, you'll enjoy a comprehensive benefits package designed to support your financial, physical, and professional well-being:

  • Competitive Financial Package: Enjoy a rewarding salary, uncapped bonus opportunities, a 401k match program, and generous paid vacation and holidays.
  • Career Development and Advancement: Unlock your potential with opportunities for growth and development throughout your entire career.
  • Continued Learning Opportunities: Grow your skills with our in-house learning platforms, offering thousands of training resources both live and online, and take advantage of tuition reimbursement for external post-secondary pursuits.
  • Service Opportunities: Make a positive impact with paid time off for volunteering in your community
Responsibilities
  • Prepare, compile, and submit regulatory dossiers for new product licensure, amendments, and renewals to the USDA Center for Veterinary Biologics.
  • Ensure ongoing compliance with USDA regulations (9 CFR) and maintain up-to-date product licenses, outlines of production, and labeling.
  • Monitor and interpret evolving regulatory requirements and communicate relevant updates to internal stakeholders.
  • Serve as a liaison between internal departments (R&D, QA/QC, Manufacturing, Marketing) and regulatory agencies.
  • Participate in cross-functional project teams to support product development from early-stage research through commercialization.
  • Responsible for coordinating responses to health authority questions, whether by disseminating to other team members, arranging meetings or personally responding.
  • Maintain accurate records and regulatory documentation in compliance with company and regulatory agency standards.
  • Support regulatory inspections and audits by USDA or international authorities.
  • Identify and mitigate regulatory risks in collaboration with quality and compliance teams.
Qualifications
  • Education and Experience:
    • Associate's Degree with 3-5 years of relevant industry experience. Bachelor's in a life science field (e.g., biology, microbiology, veterinary science, biochemistry) with 2+ years of relevant industry experience is highly preferred
  • Extensive knowledge of MS Excel, Word, and PowerPoint software
  • Excellent attention to detail required, reliable, highly motivated, ability to work independently and interacts well in a team environment.
  • Possess excellent verbal, written and interpersonal communication skills, demonstrated good technical writing skills, ability to present ideas effectively.
  • Excellent organizational and time management skills, demonstrated prioritizing, planning and project management skills.
  • Fluency in English is required (additional language(s) is a plus).
  • Experience preparing and submitting regulatory documents to USDA and responding to agency inquiries.

A post-offer background check and drug screen is required. Additional pre-employment requirements may be necessary based on position.

Kemin is an equal opportunity employer, and all reasonable accommodations will be considered.

Kemin is a drug-free and tobacco-free campus.

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