Sr. Regulatory Affairs Specialist

Hennessy Research Associates - a Kemin company is seeking a detail-oriented and experienced Regulatory Affairs Senior Specialist to join our Animal Health Biologics this role you will be responsible for preparing regulatory submission to U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) regulations and dossiers for International registration. The position is primarily focused on licensing biologics for veterinary use.

This is an excellent opportunity for a regulatory professional who has experience with veterinary biologics regulatory affairs is passionate about animal health and enjoys working in a fast-paced science-driven environment.

This position will work on-site at Hennessy Research Associates located in Lexexa Kansas

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 planets 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 3500 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 youll 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 forvolunteering in your community

• Prepare compile and submit registration documents for new product licensure to the USDA Center for Veterinary Biologics (CVB).
• Ensure documents and studies are compliant with USDA regulations (9 CFR) and maintain up-to-date product licenses outlines of production and labeling.
• Develop appropriate regulatory strategy and monitoring to provide efficient licensing of new products.
• Participate and potentially lead cross-functional project teams to support product development from early-stage research through commercialization.
• 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.
• Coordinate regulatory submissions and communications for international markets as needed.
• 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 research and development quality and production teams.

• Bachelors degree in life science field (e.g. biology microbiology veterinary science biochemistry).
• 25 years of experience in regulatory affairs with a focus on veterinary biologics.
• Strong knowledge of USDA-CVB regulatory requirements and 9 CFR.
• Experience preparing and submitting regulatory documents to USDA and responding to agency inquiries.
• Excellent written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Proficient in Microsoft Office and electronic document management systems.
• Ability to travel on occasion for off-site meetings and training. No more than 10%

Preferred:

• Graduate degree in life sciences with focus on microbiology immunology veterinary science or related degree.
• Experience with International registrations
• Some proficiency in a second language such as Spanish French or Arabic

We are an equal opportunity employer. We consider all qualified applicants without regard to race color creed/religion national origin ancestry citizenship or immigration status (where applicable) sex sexual orientation gender identity or expression pregnancy/childbirth/breastfeeding or related conditions age (40) disability (including the use of a service animal) genetic information marital status familial or caregiver status military or veteran status status as a victim of domestic violence reproductive health decisionmaking and any other status protected by applicable federal state or local law. We also prohibit retaliation for raising concerns or participating in an EEO process. Applicants who need a reasonable accommodation to apply or interview can email.

A post-offer background check and drug screen is required. Additional pre-employmentrequirementsmay be necessarybased onposition.

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

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