- 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
Manager, Regulatory Affairs in madison at Unknown Company
This position is listed as full time and onsite.