Regulatory Affairs Manager

Oterra•Sturtevant, WI

8d•Onsite

About The Position

The Regulatory Affairs Manager is responsible for leading regulatory compliance activities for Oterra's portfolio of natural colors across the United States and Canada. This role provides strategic regulatory leadership to support business growth, innovation, customer conversions from synthetic dyes to natural colors, and market expansion while ensuring compliance with all applicable food, beverage, pet food, nutraceutical, and biotechnology regulations. As the regulatory leader for North America, this position serves as the primary regulatory expert for natural colors and coloring ingredients, partnering closely with Commercial, Innovation, Product Development, Applications, Quality, Operations, and Global Regulatory teams. The Regulatory Affairs Manager will drive regulatory strategies that enable successful commercialization of new color technologies, support customer reformulation initiatives, and influence industry regulatory developments impacting the color industry.

Requirements

Bachelor's degree in Food Science, Regulatory Science, Chemistry, Biochemistry, Nutrition, Food Safety, or related scientific discipline.
10+ years of regulatory affairs experience within the food ingredient, food color, flavor, nutraceutical, or specialty ingredient industry.
Strong knowledge of FDA color additive regulations, food ingredient regulations, labeling requirements, and Health Canada regulations.
Demonstrated expertise in natural colors, coloring foodstuffs, botanical extracts, or specialty food ingredients.
Experience supporting customer compliance, product commercialization, and regulatory submissions.
Proven ability to influence cross-functional teams and drive regulatory strategy.
Strong project management, communication, and leadership skills.

Nice To Haves

Master's degree in Food Science, Regulatory Science, Chemistry, Biochemistry, or related field.
Regulatory Affairs Certification (RAC) or equivalent professional certification.
Previous people management experience.
Experience with color additive petitions, GRAS notifications, novel ingredient approvals, or international food ingredient regulations.
Active participation in NATCOL, IACM, IFT, or other food ingredient industry organizations.
Experience supporting synthetic-to-natural color conversion initiatives.

Responsibilities

Lead and oversee regulatory compliance for Oterra's portfolio of natural colors, marketed in the United States and Canada.
Develop and implement regulatory strategies to support new product launches, innovation projects, and customer conversion programs from synthetic colors to natural alternatives.
Monitor, interpret, and communicate changes to FDA, USDA, Health Canada, CFIA, California, and other applicable regulations affecting food colors and ingredients.
Evaluate regulatory risks and opportunities associated with emerging color technologies, fermentation-derived pigments, and biotechnology solutions.
Support the development and commercialization of new pigments and color solutions through regulatory assessments and approvals.
Serve as Oterra's primary representative within industry associations including NATCOL, IACM, and other relevant organizations.
Build relationships with regulatory authorities including FDA, USDA, Health Canada, and industry stakeholders.
Lead regulatory submissions, color additive petitions, GRAS assessments, certifications, registrations, and regulatory dossiers as required.
Partner with Global Regulatory Affairs to support international approvals and harmonization efforts.
Monitor legislative and regulatory developments impacting the food color industry and develop proactive business strategies.
Act as the regulatory expert supporting customer conversions from synthetic dyes to natural colors across food, beverage, confectionery, dairy, bakery, snacks, and pet food applications.
Provide regulatory guidance on ingredient declarations, color labeling requirements, claims substantiation, certifications, and market-specific compliance requirements.
Support key customer accounts by responding to complex regulatory inquiries and participating in customer meetings as needed.
Collaborate with Sales and Marketing teams to identify regulatory opportunities that support business growth and competitive differentiation.
Manage and develop the North American Regulatory Affairs team.
Partner closely with Innovation, Product Development, Applications, Quality Assurance, Quality Control, Supply Chain, and Operations teams.
Support Innovation projects by providing regulatory guidance on new raw materials, pigments, formulations, and technologies.
Train internal teams on regulatory requirements, industry trends, and food color regulations.
Establish departmental priorities, objectives, and performance metrics aligned with business goals.