Regulatory Affairs Executive

Role overview

The Regulatory Affairs Executive / Senior Executive / Assistant Manager will oversee complete compliance for nutraceutical, health supplement, and food product formulations. The position supports domestic licensing and approvals, export-related filings, label and claim review, and coordination with regulatory bodies. It plays an important role in accelerating CDMO client onboarding, enabling new launches, and keeping export operations running smoothly.

About the company

Sankalp Lifecare Pvt. Ltd. is among India’s leading nutraceutical manufacturers and operates a major zero-discharge facility in Bavla, Ahmedabad. The plant is certified by WHO-GMP, ISO, FSSAI, and FDA, and is designed for export-oriented manufacturing for the US and European markets. The company produces tablets, capsules, soft gels, gummies, effervescent tablets, powders, sachets, and liquid formulations, backed by more than 500 ready-made formulations and a client base of over 51 domestic and international customers.

Work location

Ahmedabad, Gujarat, India

Compensation

CTC offered is INR 40,000 to INR 50,000 per month, depending on experience and overall fit.

Responsibilities

• Prepare, submit, and monitor FSSAI Central Licensing applications for new products, including approvals under the Nutraceuticals Regulations, 2016 for health supplements, nutraceuticals, FSDU, FSMP, functional foods, and novel foods.
• Handle renewals, amendments, and modifications related to FSSAI licenses for the plant and product portfolio.
• Ensure ingredient selection, composition, and product labels comply with FSSAI rules, permitted limits, and mandatory labelling norms.
• Manage FoSCoS filings and keep regulatory records current for all stock keeping units.
• Coordinate with FSSAI authorities, consultants, and auditors during inspections, clarifications, and compliance queries.
• Assess proposed formulations from R&D or CDMO clients for regulatory acceptability before development begins.
• Draft regulatory dossiers, product specification sheets, and certificates of analysis to support launches.
• Review packaging and label statements such as claims, nutrient declarations, RDA percentages, warnings, and usage directions for compliance with FSSAI and Legal Metrology requirements.
• Support quicker regulatory clearance for contract manufacturing and private-label projects.
• Prepare export documents such as Certificates of Free Sale, Certificates of Origin, Health Certificates, and market-specific registration files.
• Track and apply destination-country requirements for markets including UAE, GCC, Africa, LATAM, Southeast Asia, UK, and USA.
• Work with the export team to ensure shipments carry complete and accurate compliance documentation.
• Assist with Halal, Kosher, and other certifications required by specific markets or clients.
• Support WHO-GMP, ISO, and US FDA compliance through audits, document checks, and corrective action follow-up.
• Maintain SOPs for regulatory and documentation workflows.
• Partner with QA/QC teams to ensure batch records, stability data, and test reports are suitable for regulatory submissions.
• Help prepare for external inspections and client or regulatory audits.
• Serve as the regulatory contact for CDMO and private-label clients on approvals, labelling, and timelines.
• Prepare compliance certificates and documentation bundles for onboarding and due diligence.
• Maintain a well-organized, audit-ready record of approvals, licenses, certificates, and correspondence.
• Track updates in domestic and international regulations and highlight their impact on current products and processes.
• Share periodic compliance status updates with management.

Requirements

• B.Pharm, M.Pharm, or M.Sc. in Chemistry, Biochemistry, Food Technology, or Life Sciences.
• Additional Regulatory Affairs certification such as RAC or a postgraduate diploma is preferred but not essential.
• 2 to 7 years of relevant experience in Regulatory Affairs within nutraceutical, pharmaceutical, food supplement, or FMCG health and wellness businesses.
• Practical experience with FSSAI licensing, product approvals, and FoSCoS submissions is required.
• Exposure to export documentation and international regulations such as GCC, USFDA, and EU norms will be an added advantage.
• Experience in a CDMO, contract manufacturing, or private-label setup is strongly preferred.
• Strong knowledge of FSSAI rules, Nutraceuticals Regulations 2016, and Legal Metrology labelling requirements.
• Working understanding of GMP, ISO, and quality documentation systems.
• Strong drafting, documentation, and dossier preparation abilities.
• Good coordination skills across R&D, QA, Production, and Sales/Export teams.
• Ability to manage multiple approvals and deadlines with close attention to detail.
• Comfort with MS Office and familiarity with FoSCoS and regulatory databases.
• Effective communication skills for dealing with authorities, auditors, and CDMO clients.

Perks

• No additional perks were specified in the source.

Additional information

This role is focused on nutraceuticals, pharmaceuticals, food and health supplements, and related compliance work for both domestic and export markets. The position supports markets such as Africa, CIS, Southeast Asia, LATAM, and other emerging regions. It also involves maintaining regulatory readiness for audits and helping the company deliver fast, reliable CDMO services.