Job Overview: The Regulatory Scientist is responsible for supporting regulatory compliance and product development activities for dietary supplements and nutraceutical products manufactured by DFS (Dosage Form Solutions) operations. This role ensures compliance with applicable FDA regulations, supports product lifecycle management, manages regulatory submissions and documentation, and partners cross-functionally to facilitate successful product launches and ongoing compliance initiatives.The ideal candidate will possess strong regulatory affairs experience within the dietary supplement or food industry, exceptional communication skills, and a thorough understanding of U.S. FDA requirements for dietary supplements and food manufacturing. This individual is required to follow cGMP (current Good Manufacturing Practices), all Standard Operating Procedures, and Food Safety Regulations.
Key Responsibilities:
- Provide accurate and timely responses to customer requests related to regulatory and compliance requirements for products manufactured by DFS operations, including support for:
- New or reformulated product launches
- Ingredient source changes
- Regulatory and compliance documentation requests
- Acquire, maintain, and manage all required regulatory registrations, notifications, and authorizations applicable to company operations and products.
- Serve as the primary contact during regulatory authority inspections and inquiries, including interactions with the FDA.
- Monitor and evaluate regulatory and compendial changes impacting DFS operations and assist in the development and execution of compliance action plans.
- Conduct regulatory assessments of raw materials, ingredients, and product formulas to ensure compliance with applicable standards and regulations.
- Lead risk assessment and mitigation activities associated with potential product recalls and compliance concerns.
- Support raw material qualification activities by resolving regulatory and compliance deliverables, including:
- Regulatory and quality standards
- GMO declarations
- Allergen statements
- Gluten-free declarations
- Harmful substance assessments
- Provide guidance and mentorship regarding dietary supplement labeling requirements, including the development and review of Supplement Facts panels in compliance with FDA regulations.
- Drive process improvements and operational efficiencies to ensure regulatory and compliance requirements are consistently and accurately captured.
- Collaborate with business leaders and Regulatory leadership to prioritize projects, meet deadlines, and provide effective commercial and customer support.
- Support the preparation, submission, renewal, amendment, and maintenance of regulatory filings, registrations, and periodic reports.
- Coordinate with domestic and international affiliates to compile and prepare regulatory submission documentation.
- Serve as the regulatory liaison throughout the entire product lifecycle.
- Participate in product development planning, implementation activities, and regulatory strategy discussions.
- Act as the regulatory representative for marketing, research and development, operations, and regulatory agencies.
- Manage and evaluate product changes by assessing change scope, regulatory impact, and international submission requirements.
- Maintain strong working relationships across internal departments, third-party manufacturers, suppliers, and external partners.
- Support the development of new product formulations across dietary supplement and nutraceutical categories.
- Contribute to end-to-end product development activities from concept through commercialization across multiple dosage forms and formats.
- Review and approve packaging artwork to ensure regulatory, nutritional, and scientific accuracy.
- Ensure labeling, packaging, and marketing claims comply with applicable regulatory requirements and industry standards.
- Prepare and maintain documentation required for product notifications, registrations, and regulatory submissions.
- Coordinate stability testing programs and ingredient shelf-life assessments with laboratories and manufacturing partners.
- Monitor scientific literature, industry trends, and regulatory developments to support innovation and product strategy initiatives.
Qualifications:
· Master’s degree is regulatory science
· Bachelor’s degree in chemistry, biology, or related field required with 2-3 years of experience
· Significant experience working in the dietary supplement or food industry.
· Experience in regulatory affairs.
· Solid understanding of 21 CFR 117 Requirements for Human Food and 21 CFR 111 requirements for Dietary Supplements.
· Excellent communication skills both oral and written to actively support customers and authority requests.
· Experience in FDA dietary supplement labeling
· Experienced in regulatory inspections and interactions with FDA.
· Significant experience in Microsoft Office skills (including Excel, PowerPoint, etc.)
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
