About the company:
We’re at the center of both the data-driven revolution and the online health movement with consumers rapidly shifting to digital channels and increasingly taking their health into their own hands, we believe that improving the consumer healthcare industry starts with growing individual companies and businesses with technology and data.
Job Summary
We are seeking an experienced senior regulatory person specializing in dietary supplements regulatory compliance across global markets (US, EU, Canada, UK, Australia, and other international markets). This role involves leading regulatory initiatives, ensuring compliance with international supplement regulations, and supporting market entry strategies.
The ideal candidate will have deep expertise in global dietary supplement regulatory frameworks, including:
- US FDA (DSHEA, 21 CFR Part 111 – cGMP for Dietary Supplements, NDI, GRAS regulations)
- EU Food Supplements Directive (2002/46/EC), Novel Food Regulations
- Health Canada (Natural Health Products Regulations, NPN registration)
- UK FSA & MHRA regulations for food supplements
- TGA (Australia, ARTG listings for complementary medicines)
The role will require strategic regulatory leadership, cross-functional collaboration, and engagement with regulatory authorities to maintain compliance across multiple jurisdictions.
Key Responsibilities:
Regulatory Compliance & Strategy
- Monitor and interpret dietary supplement regulations, industry trends, and compliance updates across multiple jurisdictions.
- Develop and implement regulatory strategies for dietary supplements to meet global compliance and market entry requirements.
- Ensure compliance with Good Manufacturing Practices (GMP) specific to dietary supplements (US 21 CFR Part 111, EU GMP, Canada GMP, TGA GMP).
- Provide regulatory guidance on ingredient safety, permissible health claims, labeling, and formulation restrictions.
- Advise on GRAS, NDI (New Dietary Ingredient) filings, and Novel Food applications where applicable.
Product Compliance & Market Entry Support
- Manage regulatory submissions, product registrations, and technical documentation for dietary supplements, including:
- US FDA Supplement Facts Panel compliance, GRAS notifications, NDI submissions.
- EU market compliance, including permitted ingredients, labeling, and EFSA health claim approvals.
- Health Canada NPN (Natural Product Number) applications and compliance with NHP regulations.
- UK food supplement compliance under FSA & MHRA regulations.
- TGA listing requirements for complementary medicines in Australia.
- Review and approve supplement labels, marketing materials, and advertising claims for regulatory compliance.
- Collaborate with R&D, Quality, and Marketing teams to ensure that supplement formulations align with global regulatory requirements.
- Oversee post-market surveillance (PMS), adverse event reporting (AER), and recall procedures where applicable.
Stakeholder Engagement & Audits
- Act as the primary liaison with regulatory agencies, third-party testing labs, and industry groups for dietary supplement compliance.
- Support internal and external audits, inspections, and regulatory inquiries from government authorities.
- Conduct regulatory training sessions for cross-functional teams on dietary supplement compliance best practices.
Regulatory Intelligence & Risk Management
- Continuously track and analyze changes in dietary supplement legislation, ingredient bans, and enforcement actions.
- Identify potential regulatory risks and implement proactive mitigation strategies.
- Lead regulatory impact assessments for product modifications, reformulations, and global expansion efforts.
Key Requirements: Qualifications & Experience
Education & Experience
- Minimum Bachelor’s degree in a related field.
- 5+ years of regulatory experience in dietary supplement compliance across US, EU, UK, Canada, Australia, and global markets.
- Proven experience in supplement registration, label compliance, claims substantiation, and ingredient approvals.
- Familiarity with GMP regulations (21 CFR Part 111, EU GMP, Canada GMP, TGA GMP) and risk management for supplements.
Skills & Competencies
- Strong knowledge of global dietary supplement regulations, labeling requirements, and advertising standards.
- Excellent analytical, problem-solving, and project management skills.
- Ability to interpret complex regulatory texts and communicate compliance strategies effectively.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and regulatory compliance software.
- Effective verbal and written communication skills for cross-functional collaboration.
- Ability to work independently in a remote setting while coordinating with global teams.
Preferred Qualifications
- Experience with post-market surveillance, safety reporting, and dietary supplement ingredient safety assessments.
- Knowledge of clinical substantiation of health claims, regulatory intelligence tools, and dietary supplement compliance databases.
- Professional certification Knowledge of Slack, Zoom.
**ALL APPLICANTS ARE REQUIRED TO SUBMIT A BRIEF VIDEO INTRODUCTION.**
Purpose: This video will be sent to the client for a more efficient screening process.