Job Description Regulatory Affairs Executive / Senior Executive / Asst Manager – (Nutraceuticals / Pharmaceuticals / Food & Health Supplements)

Role Purpose

The Executive Officer / Assistant Manager – Regulatory Affairs will be responsible for ensuring end-to-end regulatory compliance for all nutraceutical, health supplement, and food product formulations manufactured by Sankalp Lifecare — covering domestic FSSAI licensing and product approvals, export documentation and country-specific dossier preparation, label and claim compliance, and liaison with regulatory bodies. This role is critical to enabling faster CDMO client onboarding, new product launches, and uninterrupted export operations.

Job Summary

We are looking for a dynamic Regulatory Affairs Executive/Senior Executive to manage product registrations, regulatory approvals, and compliance activities for Nutraceutical products across international markets including Africa, CIS, Southeast Asia, LATAM, and other emerging markets. The candidate will be responsible for preparing regulatory dossiers, coordinating with regulatory authorities, ensuring compliance with country-specific regulations, and supporting timely product registrations.

Job Location: Ahmedabad, Gujarat (Head Office)

CTC: 40,000 – 50,000 per month (Based on experience and competency)

Education:

- B.Pharm / M.Pharm, or M.Sc in Chemistry, Biochemistry, Food Technology, or Life Sciences.
- Additional certification in Regulatory Affairs (e.g., RAC, PG Diploma in Regulatory Affairs) preferred but not mandatory.

Experience:

- 2–7 years of relevant experience in Regulatory Affairs within the Nutraceutical, Pharmaceutical, Food Supplement, or FMCG (Health & Wellness) industry.
- Hands-on experience with FSSAI licensing, product approvals, and FoSCoS filings is essential.
- Exposure to export documentation and international regulatory requirements (GCC, USFDA, EU) will be a strong advantage but not mandatory
- Prior experience in a CDMO / contract manufacturing / private-label environment is highly preferred.

Key Skills & Competencies

- Strong working knowledge of FSSAI regulations, the Nutraceuticals Regulations 2016, and Legal Metrology labelling requirements.
- Understanding of GMP, ISO,



and quality systems documentation.
- Excellent documentation, drafting, and dossier preparation skills.
- Strong coordination skills to work across R&D;, QA, Production, and Sales/Export teams.
- Detail-oriented with the ability to manage multiple product approvals and deadlines simultaneously.
- Proficiency in MS Office (Word, Excel, PowerPoint); familiarity with FoSCoS portal and regulatory databases.
- Good communication skills to liaise with regulatory authorities, auditors, and CDMO clients.

Key Responsibilities

1. FSSAI & Domestic Regulatory Compliance

- Prepare, file, and track FSSAI Central Licensing applications for new products, including product approvals under the Nutraceuticals Regulations, 2016 (Health Supplements, Nutraceuticals, FSDU, FSMP, Functional Foods, Novel Foods).
- Manage FSSAI license renewals, modifications, and amendments for the manufacturing facility and product portfolio.
- Ensure all products comply with permitted ingredient lists, maximum permissible limits, and labelling requirements under FSSAI regulations.
- Coordinate FoSCoS (Food Safety Compliance System) filings and maintain up-to-date regulatory documentation for all SKUs.
- Liaise with FSSAI Central/State authorities, consultants, and auditors for inspections, queries, and clarifications.

2. Product Development & New Launch Compliance

- Review new product formulations (proposed by R&D;/CDMO clients) for regulatory feasibility prior to development — flag non-compliant ingredients or claims early in the process.
- Prepare regulatory dossiers, product specification sheets, and Certificates of Analysis (COA) to support new product launches.
- Ensure label content (claims, nutrient declarations, RDA percentages, warnings, directions for use) complies with FSSAI labelling regulations and Legal Metrology requirements.




- Support rapid-track regulatory clearance for CDMO/private-label clients to reduce product time-to-market.

3. Export Regulatory Affairs

- Prepare export documentation including Certificate of Free Sale (CFS), Certificate of Origin, Health Certificates, and product registration dossiers for target export markets (UAE, GCC, Africa, LATAM, Southeast Asia, UK, USA).
- Track and ensure compliance with destination-country regulatory requirements (e.g., UAE ESMA/MOHAP, GCC Standardization Organization, US FDA facility registration and labelling norms).
- Coordinate with the export sales team to ensure all shipments are accompanied by complete and accurate regulatory documentation, minimizing customs delays.
- Support Halal, Kosher, or other market-specific certifications as required by export clients.
- 4. Quality, GMP & Audit Support

- Support maintenance of WHO-GMP, ISO, and US FDA facility compliance — assist in internal audits, documentation reviews, and corrective action tracking (CAPA).
- Maintain Standard Operating Procedures (SOPs) related to regulatory and documentation processes.
- Coordinate with QA/QC teams to ensure batch documentation, stability data, and testing reports meet regulatory submission standards.
- Assist in preparing the facility and documentation for external regulatory audits/inspections (FSSAI, FDA, client audits).

5. CDMO & Client Coordination

- Act as the regulatory point of contact for CDMO/private-label clients — addressing their regulatory queries on formulation approvals, labelling, and compliance timelines.
- Prepare regulatory compliance certificates and documentation packages to support client due-diligence and onboarding.
- Track regulatory turnaround times to support the company's commitment to fast, reliable CDMO service delivery.

6. Documentation & Regulatory Intelligence

- Maintain an organized, audit-ready repository of all regulatory licenses, approvals, certificates, and correspondence.
- Monitor changes in FSSAI regulations, nutraceutical/health supplement guidelines, and key export market regulations — proactively flag impact on existing products or processes.
- Prepare periodic regulatory compliance status reports for management.

📌 Regulatory Affairs Executive (Ahmedabad)
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📍 Ahmedabad