Associate Director, Regulatory/Scientific Affairs and Quality

Overview

Kemin Health is hiring an Associate Director of Regulatory/Scientific Affairs and Quality! In this role, you will be responsible for leading the business units’ regulatory affairs (RA) and quality assurance (QA) teams by proactively identifying and managing regulatory/quality risks and opportunities aligned with strategic direction and priorities of the business. This individual will be responsible for overseeing product compliance and registrations at state, national, and international levels. They will monitor and influence regulatory changes, support product safety, substantiate claims, and ensure label compliance. Additionally, they will provide guidance throughout all stages of innovation and commercialization, support global customers on regulatory and quality-related matters, and ensure the quality compliance of the business unit's product portfolio globally.

We Are Kemin  

We are visionaries who see things differently and are inspired by the world around us.   

We have been dedicated to using applied science to improve the quality of life for over half a century.  

We are a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services.   

For over half a century, Kemin has been dedicated to using applied science to address industry challenges and offer product solutions to customers in more than 120 countries. Kemin provides ingredients to feed a growing population with its commitment to the quality, safety and efficacy of food, feed and health-related products to customers around the world.    

Established in 1961, Kemin is a privately held, family-owned-and-operated company with more than 2,800 global employees and operations in 90 countries, including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, San Marino, Singapore, South Africa and the United States. 

As a Kemin team member, you’ll receive…  

• A competitive financial package- in addition to your salary, we offer an uncapped bonus opportunity, 401k match program, and paid vacation and holidays. 
• Robust health and wellness support- we are proud to offer a fitness reimbursement (for your whole family!), an on-site fitness center, restaurant with seasonal fresh food options (and the ability to order food to bring home), and free fresh fruit in break areas- to name a few.  

• Continued learning opportunities- Kemin offers tuition reimbursement and recently launched a new corporate university with online and in-person training opportunities for growth and development throughout your entire career.  
• The chance to give back to our world- Through our foundation of servant leadership, we are proud to offer ample service opportunities, including paid time off to do so. Kemin has a valued corporate partnership with both The World Food Programme and Habitat for Humanity, in addition to many local initiatives. 
• Opportunities to support our valued educators- Kemin is a proud sponsor of the Iowa Governor's Stem Advisory Council where we fund annual teacher's awards. In addition, we have a robust internship and externship program, and frequently host student tours. 

Responsibilities

• Responsible for leading and establishing direction for the business unit Regulatory Affairs (RA) and Quality Assurance (QA) department and working cross-functionally across business units and within the business unit to assure regulatory and quality compliance for the products marketed and sold by the primary business unit.
• Responsible for establishing and managing the RA/QA budget and departmental strategies to support the overall strategic plan 
• Work cross-functionally and provide regulatory, scientific and quality expertise and support through all stages of the innovation process, ensuring the safety, freedom-to-operate, and regulatory compliance of ingredients, contaminant legislations, and packaging materials.
• Ensure that Kemin Health ingredients, formulas, products, labels, packaging, promotional materials, and marketing communications comply with relevant local and global regulations as well as Kemin policies and guidelines in collaboration with Commercial and R&D departments.
• Lead and execute on regulatory innovative strategies for Kemin products deemed necessary to achieve business outcomes such as global regulatory approvals and clearance for Kemin Health ingredients, labels, and claims.
• Serve as official Kemin liaison to regulatory entities, including, but not limited to US FDA, EFSA, Health Canada, ANVISA, etc.
• Responsible for final review and approval of all product formulas as well as review of commercial collateral administered through Kemin’s Permission to Publish (PTP) program.
• Support Kemin Health customer needs and/or create collateral related to regulatory, claims, and quality compliance as it related to Kemin Health ingredients.
• Oversee QA for all Kemin Health products including food safety and regulatory compliance programs and systems (HACCP, GMP, Environmental Monitoring, Pest Control and Sanitation Program; hold and reject; product recovery, allergens, recalls and inspections (internal and external).
• Oversee and work closely with Central Operations and Quality on audits (regulatory and customer), supplier qualification, non-compliant product, and consumer complaints.
• Oversee quality certifications including Kosher, Halal and non-GMO Project Verification.
• Stay abreast of the changing regulatory, legal, quality and competitive landscape.
• Assess and prepare in-depth regulatory assessments and opinions as it relates to evolving business needs.
• Responsible for final review and approval of all product formulas, and product claims,, quality questions, and claim-language freedom to operate decisions for business unit product portfolio
• Determine regulatory requirements and interpret relevant government regulations to support the business unit product portfolio. Demonstrates servant leadership in all aspects of managing the RA/QA department including performance discussions, managing priorities, hiring of staff.

Qualifications

• Education & Experience: 
  • Undergraduate degree with 10+ years of experience in dietary ingredients, nutraceuticals, or food ingredient company 
  • OR an advanced degree in science or legal field with at least 5+ years of experience in dietary ingredients, nutraceuticals, or food ingredient company 
• Strong experience and understanding of U.S. (State and Federal) and relevant global laws and regulations in key regions (EU, Canada, Mexico, Brazil, APAC, Australia) as they relate to dietary ingredients including but not limited to ingredient manufacturing, safety, contaminants, quality, packaging/labels, claims and claim substantiation.
• Experience with supporting customers on regulatory and quality-related matters.
• Experience and knowledge/skills related to Quality Management Systems such as GMPs, ISO, HACCP
• Must have excellent time management and organization skills, a high energy level, and a sense of commitment and urgency to ensure obligations are met.
• Excellence in presenting, influencing, fostering relationships across global cultures
• Ability to lead and develop people, previous experience managing people required.
• Experience working with variety of government agencies.
• Experience in drafting and assembling successful regulatory dossiers that result in approval/market clearance by the US and/or foreign regulatory authorities.
• Strategic and business-impact mindset.
• Ability to influence, articulate and propose alternatives to critical decisions without compromising quality and safety.

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

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

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