Unknown Company

Manager, Regulatory Affairs

madison, wi • Posted 4 days ago
Onsite Full Time Legal

  • 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

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Manager, Regulatory Affairs in madison at Unknown Company

This position is listed as full time and onsite.

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