Director of Regulatory Affairs - Ingredients
A well-established and growing ingredient manufacturer is seeking a Director of Regulatory Affairs to lead regulatory strategy and compliance across food, beverage, and dietary supplement ingredient applications.
This role is ideal for a senior regulatory professional with strong experience in food ingredient regulations and a proven ability to support product development, commercialization, and global market access.
You will play a key role in ensuring compliance, supporting innovation, and guiding cross-functional teams through evolving regulatory requirements.
Key Responsibilities
- Develop and lead regulatory strategies ensuring compliance with FDA, USDA, FSMA, and international regulatory requirements
- Interpret and implement regulatory requirements impacting food ingredients, additives, and functional ingredients
- Monitor changes in regulatory frameworks and communicate impact to the business
- Provide regulatory guidance during new product development and commercialization
- Oversee regulatory documentation including ingredient statements, claims substantiation, compliance letters, technical data sheets, allergen and non-GMO statements, and organic documentation
- Manage regulatory submissions including GRAS notifications, food additive petitions, and international approvals
- Provide expertise on labeling, claims, and compliance across food and supplement markets
- Respond to customer regulatory requests and support commercial teams on compliant marketing claims
- Partner with R&D, Quality, Operations, and Sales to ensure regulatory compliance across product development and manufacturing
- Serve as internal subject matter expert on regulatory matters
- Lead regulatory risk assessments and mitigation strategies
- Ensure regulatory compliance across North America, Europe, and other global markets
- Support Novel Food applications and international regulatory approvals
- Coordinate with external regulatory consultants as needed
- Build, manage, and mentor the regulatory team
- Establish regulatory processes, systems, and training programs
Requirements
- Bachelor's or Master's degree in Food Science, Chemistry, Regulatory Affairs, or related field
- 10+ years of regulatory affairs experience within the food or food ingredient industry
- Strong knowledge of FDA regulations (CFR Title 21, FSMA, DSHEA, GRAS)
- Experience with global regulations including Europe (EFSA) and international markets
- Experience supporting functional or specialty food ingredients preferred
- Proven experience managing regulatory documentation and customer regulatory support
- Strong leadership and team management skills
- Excellent communication and cross-functional collaboration skills
- Ability to translate complex regulatory requirements into practical business guidance