Manager, Regulatory Affairs

Jobtailor; Madison (WI); On-site; USD 140,000 - 170,000; Full time

Job summary

Jobtailor is seeking a North American Regulatory Affairs expert to lead regulatory strategy for Food Biosciences products across the US and Canada. The role focuses on submissions, compliance, and guidance to internal teams and customers.

Responsibilities include monitoring regulatory developments, collaborating with R&D, Quality, and Commercial teams, and building relationships with authorities and industry groups to support commercialization and innovation.

Qualifications

• Master's degree in a life sciences or regulatory field.
• Significant regulatory affairs experience within food ingredients, biotechnology, dairy, enzymes, cultures, or another regulated industry
• Strong knowledge of US and/or Canadian regulatory frameworks for food ingredients and Food Biosciences products
• Hands-on experience preparing and managing regulatory submissions and notifications
• Excellent communication and stakeholder-management skills; ability to work across functions

Responsibilities

• Serve as the North American regulatory subject matter expert for Food Biosciences products, including food enzymes and cultures
• Proactively assess regulatory developments and business impact
• Develop and execute regulatory strategies supporting commercialization, innovation, and business growth across the United States and Canada
• Lead, prepare, and support regulatory submissions and notifications, including GRAS submissions and Health Canada filings
• Partner with R&D, Applications, Quality, and Commercial teams to integrate regulatory requirements into product development and launch activities
• Provide regulatory guidance to internal stakeholders and external customers regarding product compliance, regulatory status, and market requirements
• Monitor and maintain ongoing compliance of marketed products within North American regulatory frameworks and applicable industry standards
• Evaluate regulatory risks and recommend practical, business-focused solutions
• Build and maintain relationships with regulatory authorities, industry associations, and external stakeholders
• Contribute to regulatory process improvements, documentation practices, and knowledge-sharing initiatives

Skills

Regulatory affairs

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Attention to detail

Education

Master's degree in Food Science, Chemistry, Biology, Toxicology, Regulatory Affairs, or related field

Job description

• Serve as the North American regulatory subject matter expert for Food Biosciences products, including food enzymes and cultures
• Proactively assess regulatory developments and business impact
• Develop and execute regulatory strategies supporting commercialization, innovation, and business growth across the United States and Canada
• Lead, prepare, and support regulatory submissions and notifications, including GRAS submissions and Health Canada filings
• Partner with R&D, Applications, Quality, and Commercial teams to integrate regulatory requirements into product development and launch activities
• Provide regulatory guidance to internal stakeholders and external customers regarding product compliance, regulatory status, and market requirements
• Monitor and maintain ongoing compliance of marketed products within North American regulatory frameworks and applicable industry standards
• Evaluate regulatory risks and recommend practical, business-focused solutions
• Build and maintain relationships with regulatory authorities, industry associations, and external stakeholders
• Contribute to regulatory process improvements, documentation practices, and knowledge-sharing initiatives

Requirements

• Master's degree in Food Science, Chemistry, Biology, Toxicology, Regulatory Affairs, or a related scientific discipline
• Significant regulatory affairs experience within food ingredients, biotechnology, dairy, enzymes, cultures, or another regulated industry
• Strong knowledge of United States and/or Canadian regulatory frameworks applicable to food ingredients and Food Biosciences products
• Hands‑on experience preparing and managing regulatory submissions, notifications, and supporting documentation
• Proven ability to interpret and apply complex regulatory requirements to business and product-specific situations
• Strong attention to detail, documentation practices, and organizational skills
• Excellent communication, collaboration, and stakeholder‑management skills, with the ability to influence across functions and levels
• Experience working successfully within a global, matrixed organization and collaborating across cultures and regions
• Experience supporting enzyme, culture, fermentation, biotechnology, or dairy-related product portfolios
• Established relationships with North American regulatory authorities, industry associations, or external scientific networks
• Demonstrated ability to navigate ambiguity and develop creative, solution-oriented approaches to regulatory challenges

Core Competencies

Expertise in North American regulatory frameworks for Food Biosciences products, with a strong focus on regulatory submissions, compliance, and strategic guidance for commercialization and innovation. Proven ability to collaborate across functions and influence stakeholders while navigating complex regulatory environments.

Highest-signal resume keywords

• Regulatory Affairs Experience
• Regulatory Submissions Management
• Knowledge of Food Ingredients Regulations
• Stakeholder Management Skills
• Master's Degree in Food Science or Related Discipline

ATS Optimization Keywords

Hard Skills

• Regulatory Strategy Development
• GRAS Submissions
• Health Canada Filings
• Regulatory Compliance Monitoring
• Risk Evaluation and Mitigation
• Documentation Practices
• Product Development Integration
• Regulatory Guidance Provision
• Regulatory Process Improvement
• Knowledge Sharing Initiatives

Soft Skills

• Attention to Detail
• Organizational Skills
• Excellent Communication
• Collaboration Skills
• Ability to Influence

Industry Keywords

• Food Biosciences
• Food Enzymes
• Food Cultures
• Biotechnology
• Dairy Products
• Regulated Industry
• North American Regulatory Authorities
• Industry Associations
• Global Matrixed Organization
• Fermentation