Regulatory Affairs Officer

21 hours ago


Santacruz West Mumbai Maharashtra, India Globofarm International Pvt Ltd Full time

Job Profile - Regulatory Affairs (FSSAI)

Position

Regulatory Affairs - FSSAI Compliance

Location Santacruz West mumbai

Reports To

Head - Director
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.
Key Responsibilities

Regulatory Compliance & Approvals

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

**Experience**:

- Fssai : 4 years (required)

Work Location: In person



  • Santacruz West, Mumbai, Maharashtra, India Globofarm LLP Full time ₹ 30,00,000 - ₹ 35,00,000 per year

    Job Profile – Regulatory Affairs (FSSAI)PositionRegulatory Affairs – FSSAI ComplianceLocation Santacruz West mumbaiReports ToHead – DirectorRole PurposeTo 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...


  • Mumbai, Maharashtra, India Glendale Biomed Pvt. Ltd Full time

    **Vacancy**: For Regulatory affairs officer **Job description** **Roles and Responsibilities** 2) To check artworks for regulated/ semi regulated countries. 3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & TP 4) Handling of queries pertaining to regulatory submissions from various regulatory...


  • Mumbai, Maharashtra, India Kremoint Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Title / Designation Office Regulatory AffairsOrganization Name Kremoint Pharma Pvt. Ltd.Job Location VikhroliJob Description / ResponsibilitiesPrepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.Apply for Free Sale Certificate (FSC) and Product Permission...


  • Mumbai, Maharashtra, India Fusion Market Research Full time

    Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. **Typical duties include**: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating,...


  • Mumbai, Maharashtra, India MEDVARSITY ONLINE LIMITED Full time

    Job Title: Senior Executive - Regulatory Affairs UK/IE/MT Department: Regulatory Affairs Grade Level: P-2 Reports to: Manager / Sr. Manager - Regulatory Affairs Number of Reports: NONE Location: Mumbai **Main purpose of role**: To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio...


  • Wagholi, Pune, Maharashtra, India Statistical Pharma Full time

    **Regulatory Affairs Officer Duties & Responsibilities** The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities: - Preparing submissions of licence variations and renewals to strict deadlines; - Ensuring that a company’s products comply with regulations; - Keeping abreast of international legislation,...


  • Mumbai, Maharashtra, India R. Wadiwala Sec Pvt Ltd Full time

    Designation : Regulatory Affairs Specialist - Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry - Experience : Minimum 2-5 years of experience in regulatory affairs - Salary : Good Hike on Current CTC - Location : Sandhurst Road Mumbai - Head


  • Mumbai, Maharashtra, India Clini launch Business Solutions Full time

    We are seeking a knowledgeable and experienced Regulatory Affairs Specialist with expertise in the Drugs & Cosmetics Act and FSSAI regulations, as well as experience in FDA-related activities. This role is essential for ensuring robust functional and cross-functional coordination (R&D, QC, Marketing, Legal, Production, etc.) and for the transparent execution...

  • Regulatory Affairs

    2 days ago


    Mumbai, Pithampur, India Gepach International Full time US$ 80,000 - US$ 1,20,000 per year

    Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.1. Dossier Preparation and ReviewOversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with...

  • Regulatory Affairs

    4 days ago


    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...