Our client is seeking a Regulatory and Compliance Manager to lead all regulatory affairs and compliance initiatives within their rapidly expanding and innovative company specializing in dietary supplements and functional foods. This position is responsible for ensuring that all products, processes, and labeling adhere to relevant regulatory standards (including FDA, FTC, GMP, and FSMA), while also supporting product innovation and managing import/export compliance

Client Details

Our client is an innovative manufacturer operating at the crossroads of pharmaceuticals, dietary supplements, and functional foods, dedicated to advancing health and wellness through science, integrity, and forward-thinking solutions. Committed to excellence, compliance, and consumer confidence, the company delivers high-quality, market-leading products that exceed industry standards.

At its core, the organization embraces a people-centric culture, recognizing its employees as its most valuable resource. It nurtures a collaborative and innovative work environment where individuals are encouraged to grow, contribute, and thrive. With a strong emphasis on professional development, flexibility, and work-life balance, the company creates a supportive and dynamic workplace.

Purpose-driven and values-led, our client continues to push boundaries and redefine the future of health and nutrition

Description

• Regulatory Compliance Oversight: Ensure all products comply with applicable regulations and standards, including FDA (21 CFR), FSMA, DSHEA, GMP, FTC, Health Canada, EFSA, and other relevant global regulatory bodies.
• Labeling & Claims Review: Oversee the review and approval of product labels, marketing materials, and health claims to ensure compliance with legal and regulatory requirements.
• Cross-Functional Collaboration: Partner with R&D, Quality Assurance, Product Development, Marketing, and Legal teams to integrate regulatory strategies into product development and go-to-market plans.
• Regulatory Submissions & Documentation: Prepare and maintain regulatory submissions, technical files, safety dossiers, and other supporting documentation required for domestic and international product registrations and certifications.
• Audit & Inspection Readiness: Lead internal and external audits, including those by regulatory authorities and third-party certification bodies. Ensure facilities and documentation are inspection-ready at all times.
• Monitoring & Risk Assessment: Stay current with evolving regulations and proactively assess potential impacts on product lines or business operations. Provide regulatory risk assessments and solutions.
• Training & Policy Development: Develop and deliver internal training programs and standard operating procedures (SOPs) to ensure ongoing compliance across departments.
• Product Lifecycle Management: Support product launches, reformulations, and discontinuations from a regulatory perspective to ensure continued compliance throughout the product lifecycle.
• Supplier & Ingredient Compliance: Oversee supplier documentation, including ingredient specifications, certificates of analysis, and third-party testing, to ensure raw material compliance and quality.
• Ethical & Transparent Practices: Uphold ethical standards in all compliance matters and foster a culture of transparency, accountability, and continuous improvement.

Profile

• 5+ years of regulatory/compliance experience in Pharmaceuticals/ Dietary Supplements or Food
• Experience dealing with importing and exporting regulation
• Bachelor's degree in Regulatory Affairs, Food Science, Pharmaceutical Sciences, Chemistry, or a related field (Master's or RAC certification is a plus).
• Additional certifications or training in FDA regulations, GMP, HACCP, or international regulatory standards (e.g., ISO, NSF, FSSC) are highly desirable.
• Strong understanding of U.S. and global regulatory frameworks (e.g., FDA 21 CFR, DSHEA, FSMA, FTC, EFSA, TGA).

Job Offer

• Compensation up to $100,000
• 10% Bonus
• 5% 401K match
• 3 weeks PTO
• BCBS for health, Delta Dental for Dental - very affordable plans!
• More!
  

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