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Role Description

The Regulatory & Scientific Affairs Director is responsible for leading the business units’ regulatory affairs (RA) and quality assurance (QA) teams by proactively ensuring regulatory and quality compliance, scientific integrity, and managing regulatory/quality risks and opportunities aligned with strategic direction and priorities of the business. This role bridges regulatory strategy, scientific substantiation, and commercial enablement, supporting innovation and clinical research strategy, market access, and long-term brand trust.

The Director leads a global, cross-regional regulatory and quality team, providing executive-level leadership and strategic direction for all Regulatory Affairs and Quality Assurance functions across the global KH business, ensuring alignment with corporate priorities and long-term business objectives. This role partners closely with R&D, Quality, Legal, Marketing, and Commercial functions to translate regulation and science into scalable, business-ready solutions that drive growth, credibility, and long-term brand value.

Responsibilities

• Serve as a key member of the KH Executive Leadership Team, contributing to the creation, communication, and execution of the global strategic plan, including ownership of performance metrics, budgetary targets, and operational excellence initiatives.
• Build, lead, and inspire a high-performing global RA/QA organization, including RA/QA budget management, succession planning, organizational design, and leadership development.
• Ensure the team has the capabilities, tools, and resources required to deliver world-class performance.
• Drive a culture of scientific integrity, accountability, and business partnership.
• Define and execute global regulatory strategies for new and existing food ingredients, functional foods, and nutrition platforms across key regions (US, EU, LATAM, APAC).
• Lead regulatory strategy and identify pathways for innovation projects, including new ingredients, processing technologies, line extensions, and manufacturing changes.
• Oversee preparation and submission of regulatory dossiers (e.g., GRAS, Novel Food, food additive approvals, notifications).
• Monitor regulatory developments and enforcement trends; assess risk and proactively advise the business on impact and mitigation and strengthen the organization’s competitive position.
• Ensure compliance for labeling, specifications, contaminants, usage levels, and market claims.
• Champion continuous improvement across all quality systems, redefining and optimizing quality programs, processes, and standards to ensure efficiency, scalability, and proactive risk mitigation.
• Oversee quality certifications including Kosher, Halal and non-GMO Project Verification.
• Serve as a core contributor to the innovation pipeline, supporting ideation through commercialization.
• Partner with R&D and Commercial teams to assess regulatory feasibility, safety, scientific credibility, and differentiation early in development.
• Provide clear regulatory and scientific guardrails to accelerate innovation while avoiding late-stage surprises.
• Support stage-gate decision making with risk-based regulatory and evidence assessments.
• Support platform thinking by identifying claim frameworks and evidence strategies that support multiple applications and regions.
• Define scientific substantiation strategies aligned with regulatory requirements and commercial positioning.
• Support R&D clinical research strategy, including partnering with commercial on appropriate integration of preclinical, mechanistic, and clinical data into a cohesive evidence package.
• Support publication planning, scientific communications, and data transparency.
• Serve as the senior KH representative and primary KH liaison to major global regulatory authorities, including but not limited to the U.S. FDA, EFSA, ANVISA, Health Canada and other international agencies.
• Build and maintain strong relationships to anticipate regulatory trends and influence policy direction.
• Lead regulatory advocacy efforts through trade associations, consortia, and industry initiatives.
• Engage with regulators, policymakers, and scientific bodies to support science-based regulation and fair market frameworks.
• Shape company positions on emerging regulatory and scientific topics relevant to food and nutrition.
• Support external education through white papers, presentations, panels, and customer-facing science.
• Build and maintain relationships with key opinion leaders and academic collaborators.
• Partner with Marketing, R&D, Quality, Operations and Supply Chain on supplier qualification, specifications, change management, non-compliant product, customer complaints and risk assessment.
• Ensure that KH 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.
• 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 KH customer needs and/or create collateral related to regulatory, claims, and quality compliance as it related to KH ingredients.

Qualifications

• Advanced degree (MS, PhD, DVM, or JD) in a scientific, technical, or regulatory field strongly preferred, with 10+ years of progressive leadership experience in regulatory affairs, quality assurance, or compliance within pharmaceuticals, nutraceuticals, biotechnology, or food ingredient industries.
• Bachelor’s degree with significant senior-level experience may be considered.
• Exceptional leadership capability, with a proven track record of building, developing, and guiding high-performing teams across multiple geographies and functions.
• Demonstrated success leading regulatory, scientific and quality strategy for complex product portfolios on a global scale, including experience influencing regulatory pathways and shaping compliance frameworks.
• Extensive experience interacting with U.S. and international regulatory agencies, such as FDA, USDA, EFSA, ANVISA, Health Canada, or equivalent global entities.
• Expertise in regulatory and quality management frameworks, such as ISO standards, HACCP, GMPs, and other industry relevant certifications.
• Outstanding communication, executive level presentation, and cross cultural influence skills, with the ability to drive alignment and foster collaboration across global stakeholders.
• Proven ability to lead the preparation and execution of complex regulatory dossiers that achieve successful approvals across multiple regulatory jurisdictions.
• Strategic, enterprise minded decision maker with the ability to connect regulatory and quality decisions to broader business impact and long term organizational objectives.
• Strong analytical judgment with the ability to challenge assumptions, propose alternatives, and influence critical decisions without compromising product safety or quality.
• Demonstrated ability to operate as a change leader, effectively navigating evolving regulatory landscapes and driving continuous improvement in systems, processes.

Benefits

• 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.

Company Description

Kemin is 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.