Regulatory Compliance Manager Supplements & Formulated Products

Role Overview:

The Regulatory Compliance Manager will be responsible for overseeing all aspects of regulatory compliance concerning the sale of dietary supplements and formulated products across multiple markets, focusing on the U.S., Canada, the U.K., and Europe. This role involves ensuring that products meet regulatory requirements at local, national, and international levels, while maintaining the integrity and quality of our product offerings. The manager will ensure compliance with relevant FDA, Health Canada, MHRA, EFSA regulations, and other regional guidelines while ensuring adherence to e-commerce platform-specific policies, particularly Amazon’s requirements.

Key Responsibilities:

• Regulatory Compliance & Strategy:
  • Ensure compliance with applicable regulations for dietary supplements and formulated products in the U.S., Canada, the U.K., and Europe, including FDA (Food and Drug Administration) regulations (USA), Health Canada regulations (Canada), MHRA (Medicines and Healthcare products Regulatory Agency) standards (UK), and EFSA (European Food Safety Authority) guidelines (EU).
  • Develop and implement strategies to ensure all products comply with local regulatory requirements, including product formulations, labelling, claims, and marketing in each region.
  • Monitor and assess evolving regulatory changes in all regions, ensuring products and operations are continuously compliant.
• Product Listings & Labelling:
  • Oversee the review and approval of all product labels, claims, and packaging to ensure compliance with U.S., Canadian, U.K., and European regulatory standards.
  • Work closely with the marketing and product development teams to ensure all product descriptions, images, and claims are regulatory compliant across multiple platforms, especially Amazon.
  • Ensure compliance with the labelling requirements specific to each region (e.g., nutrition labelling in the U.S., health claims in the EU, bilingual labelling in Canada).
• Amazon-Specific Compliance:
  • Manage Amazon’s regulatory compliance process for all products sold in the U.S., Canada, the U.K., and Europe, ensuring product listings meet Amazon’s requirements and platform policies.
  • Ensure that all products meet Amazon’s safety, regulatory, and quality standards, including providing required documentation (e.g., certificates of analysis, GMP certifications) for listing approval.
  • Respond to any compliance-related issues or warnings from Amazon, ensuring timely resolution and maintaining account health.
• Documentation & Record-Keeping:
  • Maintain detailed records of product compliance, including regulatory approvals, certificates, test results, and product formulations, for all regions.
  • Develop and enforce standardized procedures for document management to ensure smooth audits and regulatory inspections in all operating markets.
• Cross-Functional Collaboration:
  • Collaborate with internal teams (NPD, Marketing, Quality Control) to ensure seamless regulatory compliance across multiple regions.
  • Work with external third-party labs, certification bodies, and regulatory consultants to ensure products meet regional compliance requirements.
• Training & Education:
  • Provide ongoing regulatory training and guidance to internal teams, ensuring compliance with regional regulations and Amazon policies across all markets.
  • Develop and implement regular internal compliance audits to ensure continuous adherence to the relevant regulations in the U.S., Canada, the U.K., and Europe.
• Risk Management:
  • Identify and mitigate risks associated with non-compliance in each of the regions, including potential issues with product recalls, legal action, or suspension of Amazon accounts.
  • Develop and execute risk mitigation strategies to address emerging regulatory trends or platform-specific compliance challenges.
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Qualifications & Skills:

•  Education:
  • Bachelor’s degree in Regulatory Affairs, Law, Life Sciences, Chemistry, or a related field. Advanced degree or certifications in regulatory affairs (e.g., RAC) preferred.
• Experience:
  • 5+ years of regulatory compliance experience, with a focus on dietary supplements, health products, or food products selling into UK EU US markets.
  • Experience managing compliance for e-commerce platforms, specifically Amazon, including familiarity with Amazon’s Seller Central and product compliance policies is preferred.
  • Familiarity with product certifications such as GMP, NSF is preferred.
• Skills:
  • Deep understanding of dietary supplement labelling, health claims, ingredient regulations, and safety standards in multiple regions.
  • Strong organizational skills, with the ability to manage multiple markets’ regulatory requirements simultaneously.
  • Excellent written and verbal communication skills, with the ability to convey complex regulatory information to internal teams and stakeholders.
  • Strong problem-solving skills and the ability to work independently with minimal supervision.
  • Excellent business software skills, with proficiency in Word, Excel, and PowerPoint.
  • Excellent written and verbal communication skills, with a strong command of the English language essential for regulatory documentation, labelling reviews, and cross-functional communication.

Preferred Skills:

• Experience with international regulatory requirements for dietary supplements, including EFSA guidelines (EU), MHRA regulations (UK), and Health Canada standards.
• Knowledge of regional-specific requirements, such as bilingual labelling in Canada or unique health claims allowed in the EU.
• Experience in risk management, compliance auditing, and navigating the regulatory landscape for e-commerce in multiple regions.