Director of Regulatory Affairs - BodyBio : Job Details

About BodyBio

BodyBio is a third-generation, family-owned company that's been pioneering cellular health since 1998. Built on a foundation of clinical research and rooted in real-world results, we develop science-backed supplements that support foundational wellness—from brain to gut to mitochondria. Named one of Inc.'s Best Workplaces of 2025, our mission is to empower optimal health by restoring function at the cellular level.

Job Summary

The Director of Regulatory Affairs will lead BodyBio's regulatory strategy and execution across all product categories, including dietary supplements, functional foods, and international expansion initiatives. This individual will ensure all products and marketing materials comply with U.S. and global regulatory requirements (FDA, FTC, DSHEA, Health Canada, EU, APAC, etc.) and guide cross-functional teams in aligning scientific innovation with regulatory pathways.

As BodyBio scales rapidly—both direct-to-consumer and in clinical markets—this role is essential in upholding our high standards of safety, transparency, and credibility.

Responsibilities

Regulatory Strategy & Oversight

• Serve as the organization's regulatory lead and primary point of contact for U.S. and international compliance matters.
• Develop a regulatory roadmap aligned with product launches, market entry, and corporate goals.
• Interpret and implement U.S. and global dietary supplement and functional food regulations (e.g., FDA, FTC, DSHEA, Prop 65, Health Canada NHP, EU, TGA).
• Monitor regulatory changes and enforcement trends (e.g., FDA warning letters, SFC guidance), updating policies and advising leadership accordingly.

Product & Claims Compliance (U.S. Market)

• Ensure structure/function claims are filed with the FDA across labels, website, blog, and social media; prioritize overdue claims.
• Review and revise noncompliant marketing claims.
• Lead compliance review of social media advertisements and advise on claim substantiation.
• Oversee label revision controls, including claim language, allergen declarations, country-of-origin labeling, and documentation.
• Ensure U.S. website content meets FDA/FTC standards.
• Maintain compliance with country-of-origin labeling regulations as advised by Sheppard Mullin (e.g., ingredient sourcing transparency).

International Regulatory Affairs

• Manage product and marketing compliance for each international market.
• Oversee UK website compliance, including image and content alignment with UK labeling standards; ensure removal of U.S.-based health claims.
• Lead compliance updates on peel-and-reveal labels and coordinate Sodium Butyrate testing/labeling for France.
• Ensure compliance with Pan-European Extended Producer Responsibility (EPR) regulations:
• Germany – LUCID number
• France – UIN
• Spain – Registration with Producer Responsibility Organization (PRO) for each product category

Canada Regulatory Compliance

• Manage label compliance and regulatory filings in accordance with Health Canada requirements.
• Oversee onboarding and communication with new Canadian regulatory and logistics partners.
• Guide company adaptation to Bill 96, including French language requirements for product packaging, marketing, and websites.

Clinical Trials

• Serve as regulatory project manager for:
• U.S. Clinical Trial
• VA Trial
• Texas Christian University Trial (including paperwork review and IRB coordination)

Fraud Mitigation & Legal Coordination

• Oversee collaboration with Vorys in managing unauthorized seller issues.
• Review legal documents prepared by external counsel to ensure BodyBio retains the right to take action related to product quality (e.g., storage, handling, and distribution).
• Support legal team with regulatory enforcement defense or action, ensuring BodyBio is not unduly exposed in settlements.

Training & Internal SOPs

• Develop and implement SOPs to support regulatory compliance across departments.
• Train marketing, customer experience, and product teams on claims compliance and labeling standards.
• Guide cross-functional stakeholders on emerging compliance issues and preventive strategies.

Qualifications

• Bachelor's or advanced degree in regulatory affairs, life sciences, nutrition, pharmacology, or a related field.
• 5+ years experience in regulatory affairs within the dietary supplement, functional food, or natural health product industries.
• 3+ management and cross-functional leadership experience.
• In-depth knowledge of U.S. supplement regulations (DSHEA, FDA, FTC) and familiarity with global regulatory frameworks.
• Demonstrated success in label compliance, product development input, and international submissions.
• Strong strategic, and project management experience
• Excellent communication, attention to detail, and problem-solving skills.
• Experience coordinating legal counsel on compliance and enforcement strategies.

Equal Opportunity Employer Statement

BodyBio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other legally protected status.

All internal applicants are encouraged and welcome to apply*