Regulatory Affairs Specialist

Regulatory Compliance Officer/ Specialist – Dietary Supplements

Education: Bachelor’s/Master’s degree in Pharmacy, Food Science, Nutrition, Biotechnology, or Regulatory Affairs.

Experience: Minimum 3–5 years in product regulatory compliance, preferably in dietary supplements, cosmetics, or nutraceuticals.

KeyResponsibilities:

• Ensure all dietary supplements comply with U.S. FDA Dietary Supplement regulations under the FD&C Act and 21 CFR 111 (cGMP).
• Review and verify supplier documentation, including Certificates of Analysis (COA), GMP certificates, NDI notifications, product dossiers, permitted ingredients, prohibited or restricted ingredients and formulation specifications.
• Ensure scientific substantiation of ingredient functions and claims.
• Review all product labels, claims and Amazon listings for compliance with FDA labeling guidelines (identity statement, net quantity, Supplement Facts, ingredient declaration, warnings).
• Communicate with suppliers to ensure documentation completeness, GMP certification, facility registration, and FDA establishment listing and product conformity.
• Evaluate supplier test data for microbial, heavy metals, and purity compliance.
• Ensure all required premarket notifications (e.g., NDIN, if applicable) are filed or confirmed by the supplier, manage product listing on Amazon and FDA notification (via SPL) if needed.
• Oversee post-market vigilance, including consumer complaint tracking, recall coordination, and adverse event reporting.
• Work closely with QA/QC, Procurement, and Marketing teams to integrate regulatory compliance early in product selection.
• Support packaging and labeling approval cycles before production.

Job Type: Full-time

Work Location: In person