Regulatory Affairs Officer

Job Profile – Regulatory Affairs (FSSAI)

Position

Regulatory Affairs – FSSAI Compliance

Location Santacruz West mumbai

Reports To

Head – Director

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Role Purpose

To ensure that all nutraceutical, pharmaceutical ingredients, oils, botanicals, and food products marketed/imported/distributed by the company are fully compliant with FSSAI regulations and other applicable Indian food & nutraceutical laws. The role will support approvals, licensing, product registration, labeling compliance, and liaison with FSSAI authorities.

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Key Responsibilities

Regulatory Compliance & Approvals

Prepare and submit applications for:

Product approvals (including Non-Specified Food Ingredient applications under FSSAI).

Import clearances via Food Import Clearance System (FICS).

FSSAI licenses and renewals (central/state).

Review scientific dossiers for nutraceuticals, botanicals, and food ingredients in line with FSSAI guidance.

Track and interpret regulatory updates, draft notifications, and amendments impacting nutraceuticals, APIs, and ingredients.

Documentation & Dossier Preparation

Compile product technical files (COA, stability, safety/toxicology data, manufacturing process).

Ensure alignment with FSSAI Schedule IV requirements, labeling standards, and packaging regulations.

Maintain regulatory documentation repository for audits and inspections.

Liaison & Representation

Act as the point of contact with FSSAI authorities, testing labs, and regulatory consultants.

Represent the company in FSSAI hearings, clarifications, or industry association meetings.

Coordinate with internal R&D, Quality, and Business teams to ensure product launches are compliant.

Labeling & Claims

Review product artwork, labels, and promotional materials to ensure compliance with FSSAI labeling regulations.

Validate permissible nutrition and health claims.

Audit & Inspection Support

Prepare company records and sites for FSSAI inspections or audits.

Support AEO, GMP, HACCP, and ISO documentation where relevant.

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Qualifications & Skills

Education

B.Pharm / M.Pharm / M.Sc. (Food Technology, Biotechnology, Nutrition, or related).

Regulatory Affairs diploma/short course preferred.

Experience

2–6 years (Executive) or 6–12 years (Manager) of hands-on FSSAI regulatory affairs in nutraceuticals, food ingredients, or pharma-nutra space.

Experience with non-specified food approvals, nutraceutical product registrations, and import clearance highly desirable.

Technical Knowledge

Deep understanding of Food Safety and Standards Act (FSS Act), FSSAI regulations, and related notifications.

Familiarity with Codex Alimentarius and international regulations (US FDA, EFSA) is a plus.

Knowledge of laboratory testing protocols (microbiology, heavy metals, pesticide residues).

Skills

Strong regulatory writing, dossier compilation, and documentation skills.

Excellent liaison and negotiation ability with regulatory bodies.

Detail-oriented with strong organizational and project management skills.

Proficiency with MS Office, regulatory portals (FoSCoS, FICS).

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Key Performance Indicators (KPIs)

On-time product approval & license renewals.

Zero non-compliance observations in audits.

Reduction in import clearance delays.

Number of new product approvals obtained annually.

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Job Type: Full-time

Pay: ₹350,000.00 - ₹420,000.00 per year

Experience:

• Fssai : 4 years (Required)

Work Location: In person