Sr. Executive Regulatory Affairs

Key Regulatory Responsibilities

• Product Classification
• Determine if the product is a nutraceutical, food, drug, or cosmetic.
• Classification impacts regulatory pathway.
• Ingredient Compliance
• Ensure all ingredients are approved and within limits.
• Handle Novel Ingredients appropriately.
• Labeling and Claims
• Verify compliance with local regulations.
• Monitor for misleading or disease-related claims.
• Include required disclaimers (e.g., "This product is not intended to diagnose, treat, cure, or prevent any disease").
• Safety and Quality
• GMP compliance.
• Ensure stability, purity, and contaminant limits.
• Maintain product dossiers for inspections.
• Advertising and Promotion
• Claims must be substantiated with scientific evidence.
• Must follow local advertising guidelines.
• Regulatory Submissions and Dossiers
• Prepare and submit documentation for product approval (if required).
• Includes safety data, ingredient sources, certificates, manufacturing details.

1. Global Regulatory Landscape1. United States – FDA (Food and Drug Administration)

• Regulates nutraceuticals under the Dietary Supplement Health and Education Act (DSHEA), 1994.
• Products are regulated as food, not drugs.
• No pre-market approval required, but companies must ensure:
• GMP compliance (Good Manufacturing Practice)
• New Dietary Ingredient (NDI) notification if applicable
• Claims must be truthful and not misleading.

2. European Union – EFSA (European Food Safety Authority)

• Products categorized as food supplements.
• Requires novel food approval for new ingredients.
• Health claims must be pre-approved under Regulation (EC) No 1924/2006.
• Labeling must comply with EU food labeling laws.

3. India – FSSAI (Food Safety and Standards Authority of India)

• Nutraceuticals fall under FSSAI regulations: "Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Functional Foods, and Novel Foods) Regulations, 2022".
• Requires product licensing, label approval, and compliance with ingredient lists and limits.
• Cannot claim to treat or cure diseases.

4. Canada – Health Canada

• Regulated under the Natural Health Products Regulations.
• Pre-market approval and product licensing required.
• Strict rules for ingredients, claims, safety, and efficacy.

5. Other Markets

• Each country has its own authority (e.g., TGA in Australia, SFDA in China).
• Regulations vary widely in permissible ingredients, health claims, and approval requirements.

Job Type: Full-time

Pay: ₹15,000.00 - ₹40,000.00 per month

Work Location: In person