Senior Manager, Regulatory Commercialization
- Hiring from
- United States
- Work type
- Hybrid
- Posted
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Your Opportunity as the Senior Manager, Regulatory Commercialization
Lead the enterprise Regulatory Commercialization function responsible for enabling compliant innovation and commercialization across all company products, categories, and strategic business areas. Establish the function’s strategy, governance, standards, decision frameworks, and operating practices for ingredient reviews, claims substantiation, product changes, and commercialization decisions.
Lead a team of regulatory professionals and apply risk-based judgment to complex, novel, and high-impact regulatory matters. As a strategic business partner, you will work across Research and Development, Marketing, Legal, Quality Assurance, Procurement, Supply Chain, Commercial Operations, and business leadership to identify regulatory requirements and risks early, develop practical solutions, and support compliant innovation, speed to market, and sustainable business growth.
Location: Orrville, Ohio
Work Arrangements: Hybrid, 35% in office expectation
In this role you will:
Lead Regulatory Commercialization Strategy and Governance
- Lead the Regulatory Commercialization team responsible for providing strategic regulatory leadership throughout the commercialization process across all company products and categories.
- Establish and maintain enterprise standards and governance for innovation, reformulations, line extensions, productivity initiatives, supplier changes, business-continuity projects, and packaging changes.
- Develop effective business processes, decision rights, escalation protocols, risk-tiering criteria, and service expectations that accelerate commercialization while supporting consistent, timely, and defensible regulatory decisions.
- Partner with Marketing, Research and Development, Commercial Operations, Legal, Creative and Design, Quality Assurance, and business leaders to remove barriers and advance company priorities.
- Influence enterprise-level decisions through expert regulatory guidance and balanced, pragmatic, risk-based recommendations.
- Deliver executive-ready recommendations that clearly communicate facts, uncertainties, options, business implications, and recommended actions.
Lead Ingredient Approval Strategy and Technical Programs
- Own enterprise governance, review processes, and decision standards for ingredient authorizations, Generally Recognized as Safe determinations, novel-food processes, food-contact notifications, expanded-use approvals, and other applicable pathways.
- Determine appropriate regulatory pathways and establish scientific, documentation, and decision criteria for complex or business-critical ingredient initiatives.
- Oversee cross-functional project plans, data-gap resolution, external expert engagement, and interactions with regulatory authorities.
- Review and approve significant regulatory conclusions, ensuring decision records are scientifically sound, complete, and defensible.
- Manage specialized external toxicology resources needed to support ingredient approval programs.
Lead Regulatory Claims and Substantiation
- Establish enterprise claims policies, guardrails, substantiation standards, approval requirements, and documentation practices.
- Provide expert regulatory guidance for product claims across company categories, including nutrient-content, health-related, natural, clean-label, sustainability, caffeine, functional, and comparative claims.
- Evaluate regulatory risk and substantiation sufficiency while developing practical mitigation options that balance compliance requirements with business objectives.
- Partner with Legal on advertising, consumer-protection, class-action, National Advertising Division, Federal Trade Commission, and competitor-challenge matters.
- Escalate high-risk or precedent-setting matters with a clear assessment of uncertainties, business implications, options, and recommendations.
- Manage specialized external scientific resources supporting complex claims substantiation.
Support Regulatory Monitoring, Response, and Advocacy
- Assess evolving federal and state regulations, enforcement activity, consumer-protection issues, and industry trends that could affect commercialization priorities or portfolio risk.
- Translate external developments into enterprise impact assessments, portfolio priorities, updated standards, implementation plans, and executive recommendations.
- Collaborate with Government Relations and other cross-functional partners to shape advocacy positions aligned with business priorities.
- Represent the company in trade associations, technical organizations, regulatory engagements, and other external forums.
Lead and Develop the Regulatory Commercialization Team
- Establish team priorities, allocate resources, and balance cross-functional dependencies to deliver strategic business area and enterprise objectives.
- Lead and develop a team of three to four regulatory professionals, fostering engagement, accountability, high performance, and continuous improvement.
- Provide clear direction, priorities, and goals aligned with departmental and organizational strategies.
- Oversee regulatory support for approximately 270 to 290 commercialization projects and 110 to 120 claims-review projects annually across Coffee, Consumer Foods, Pet, and Sweet Baked Snacks.
- Manage an external toxicology budget of approximately $450,000.
What we are looking for:
Minimum requirements:
- Bachelor’s degree in Nutrition, Food Science, Regulatory Affairs, or a related field.
- 10+ years of progressive experience in Regulatory Affairs, Product Compliance, Food Law Compliance, Research and Development, Quality, or a related technical discipline within the consumer packaged goods, food, beverage, coffee, or pet food industries.
- Strong knowledge of applicable U.S. Food and Drug Administration, U.S. Department of Agriculture, Federal Trade Commission, Association of American Feed Control Officials, and other food or pet food regulatory frameworks.
- Experience supporting product development and commercialization, including reformulations, packaging changes, supplier changes, cost-savings initiatives, and business-continuity projects.
- Experience managing complex or high-risk matters involving ingredients, formulas, labels, claims, certifications, or packaging.
- Experience leading or developing regulatory professionals or other technical employees.
- Experience creating enterprise standards, governance processes, playbooks, decision trees, risk-tiering criteria, or regulatory training.
- Working knowledge of human or animal food requirements related to labeling, ingredients, food additives, Generally Recognized as Safe status, color additives, processing aids, flavors, fortification, novel ingredients, and food-contact substances.
- Ability to evaluate regulatory implications across ingredients, formulas, allergens, standards of identity, certifications, labels, and claims.
- Strong risk-based judgment and the ability to distinguish routine matters from novel, ambiguous, high-risk, or precedent-setting issues.
- Ability to conduct gap analyses and risk assessments and translate findings into clear, actionable business recommendations.
- Strong written and verbal communication skills with the ability to influence technical, commercial, legal, and leadership audiences.
- Demonstrated business acumen and the ability to manage competing priorities, navigate ambiguity, and build effective cross-functional relationships.
Additional skills and experience we think would make someone successful in this role:
- Advanced degree in Nutrition, Food Science, Regulatory Affairs, Toxicology, or a related field, or Registered Dietitian credential.
- Experience partnering with Legal on advertising, consumer-protection, class-action, National Advertising Division, Federal Trade Commission, or competitor-challenge matters.
- Experience supporting regulatory advocacy or participating in trade associations and technical organizations.
- Experience managing external consultants, scientific experts, certification bodies, or specialized service providers.
- Ability to invite diverse perspectives, create alignment, and influence decisions without unnecessary escalation.
- Ability to challenge established practices constructively and take a clear, well-supported position when needed.
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