- Manage end-to-end regulatory compliance for domestic markets covering herbal extracts, intermediates, and finished products.

- Coordinate AYUSH regulatory requirements, including preparation and maintenance of licensing documentation, facilitating third-party audits, and acting as a liaison between plants and regulatory bodies in line with Schedule T across all manufacturing locations.

- Handle FSSAI compliance, including documentation for mandatory six-monthly testing, preparation and submission of annual returns (Form D1), and proficient use of FoSCoS and related government portals.

- Review artwork and labelling submissions under guidance to ensure compliance and minimize errors for cosmetics and nutraceutical products based on legal metrology guidelines.

- Oversee Drug regulatory compliance, including licensing documentation, third-party audits, and plant-to-plant coordination as per Schedule M, T and FSSAI guidelines.

- Prepare and maintain statutory documentation related to Legal Metrology, Biodiversity Act, Phyto sanitary and other applicable Indian regulatory submissions.

- Support internal compliance checks and readiness for regulatory inspections at manufacturing plants and warehouses.

- Prepare and manage regulatory and technical documentation for exports across multiple geographies, including EU, USA, UK, GCC, ASEAN, and other international markets,



with hands-on experience in relevant online regulatory portals.

- Develop and review technical documents such as Product Data Sheets (PDS), Allergen Statements, Certificates of Composition, Manufacturing Process Flow Diagrams, and Safety Data Sheets (SDS).

- Prepare and maintain Drug Master Files (DMFs) and regulatory dossiers in compliance with ICH guidelines, including CTD and A-CTD formats.

- Coordinate documentation and submissions for animal health product registrations across international regions.

- Manage and support certification programs such as HALAL (MUI / IFANCA/JUHF), KOSHER, Non-GMO, ISO, FSSC, HACCP, and other quality or compliance certifications.

Audit & Compliance Support Manufacturing Units & Warehouses

- Assist in internal audits, third-party audits, and regulatory inspections at manufacturing plants and warehouses.

- Support GMP, Client and compliance audits, including documentation review, gap assessments, and corrective and preventive action (CAPA) tracking.

- Participate in warehouse audits covering inventory controls, traceability, storage conditions, labelling, and dispatch compliance.

- Ensure audit readiness by maintaining updated documentation, records, and compliance registers across all sites.

- Coordinate audit responses and follow-up actions with cross-functional teams including Quality, Production, Supply Chain, and EHS.

📌 Regulatory Affairs Executive (Bengaluru)
🏢 SAMI-SABINSA GROUP
📍 Bengaluru