Regulatory Affairs Officer
18 hours ago
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
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.
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.
--
Job Type: Full-time
Pay: ₹350, ₹420,000.00 per year
Experience:
- Fssai : 4 years (Required)
Work Location: In person
-
Regulatory Affairs Officer
1 week ago
Andheri West, Mumbai, Maharashtra, India Oxford Laboratories Pvt Ltd Full time ₹ 40,00,000 - ₹ 1,20,00,000 per yearOxford currently Looking for – Regulatory Affairs Officer for Mumbai H.Q.Roles and Responsibilities:The Regulatory Affairs Officer will provide support to the Regulatory Affairs Manager and assist in -Independent preparation of CTD dossier along with complete regulatory compilation like Notarized / Apostle documents, registration samples etc. for timely...
-
Regulatory Affairs Officer
7 days ago
Mumbai, India Agile Consultants Full time**Job Code**:047/001/753 **Location**:Mumbai **Salary**:Based on experience **Industry**:Chemical Manufacturing Our client is hiring an experienced Regulatory Affairs Officer who can provide guidance and support sites with the implementation of Raw Materials such as Lubricant Additives, Epoxy Paints & Coatings, Rubber/Carbon Black, Coating, Foam, and...
-
Regulatory Affairs Officer
24 hours ago
Mumbai, Maharashtra, India MEDVARSITY ONLINE LIMITED Full timeJob 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...
-
Regulatory Affairs Executive
3 days ago
Mumbai, Maharashtra, India R. Wadiwala Sec Pvt Ltd Full timeDesignation : 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
-
Regulatory Affairs Officer
5 days ago
Mumbai, Maharashtra, India TheTalentforte.com Full timeWe are looking for **REGULATORY AFFAIRS OFFICER** - BPharma / MPharma / BSc / MSc - 1 - 2 years experience in Regulatory Affairs or relevant (_Freshers please do not apply_) - English Speaking is a Must - Work Timings: Mon to Sat, 10am to 6pm (2nd & 4th sat off) - Salary 18 to 22000 PM, depending on suitability **Should be able to handle**: 1. Preparation,...
-
Regulatory Affairs Officer
7 days ago
Manjri, Pune, Maharashtra, India Fusion Market Research Full time_**Duties/Responsibilities**:_ - Works in the regulatory affairs department on assigned projects. - Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies. - Collaborates with key staff from Planning, Product Development,...
-
Regulatory Affairs Officer
7 days ago
Mumbai, India Zieva Farm Pvt Lt Full timeManage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies - Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc. - Provide expert regulatory input...
-
Regulatory Affairs Officer
24 hours ago
Mumbai, Maharashtra, India Acme Services Full time1. Management of product lifecycle for Particular Market. 2. Dossier Preparation - 3. Query Response 4. Post Approval changes 5. Variation Filing 6. Coordination with cross functional team 7. Module 1-5 8. In EUROPE MRP,DCP & National 10. Reviewing Product information as per QRD Requirement **Job Types**: Full-time, Permanent **Salary**: ₹300,000.00 -...
-
Regulatory Affairs
23 hours ago
Mumbai, Maharashtra, India Actide International Full time ₹ 6,00,000 - ₹ 12,00,000 per yearJob Description:works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.They must have excellent organizational, analytical, project management, and communication skills.They work frequently with other employees and team members to coordinate complex activities, often with...
-
Regulatory Affairs Executive(Female)
7 days ago
Mumbai, Maharashtra, India Double HR Consultancy Full timeVACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in...
