Executive / Senior Executive - Regulatory Affairs

Sami Sabinsa Group; Bengaluru; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Sami Sabinsa Group in Bengaluru seeks a regulatory affairs specialist to manage end-to-end compliance for domestic and export markets. The role covers AYUSH, FSSAI, and drug regulatory submissions, with liaison across plants and authorities.

Responsibilities include documentation, audits, and certification management (HALAL, ISO, HACCP), plus readiness for regulatory inspections and global dossier preparation.

Responsibilities

• Manage end-to-end regulatory compliance for domestic markets covering herbal extracts, intermediates, and finished products.
• Coordinate AYUSH regulatory requirements, licensing documentation, third-party audits, and liaison between plants and regulators per Schedule T across locations.
• Handle FSSAI compliance including six-monthly testing, annual returns (Form D1), and use of FoSCoS and related portals.
• Review artwork and labelling submissions under legal metrology guidelines for cosmetics and nutraceuticals.
• Oversee Drug regulatory compliance including licensing, audits, and plant-to-plant coordination per Schedule M, T and FSSAI guidelines.
• Prepare and maintain statutory docs for Legal Metrology, Biodiversity Act, Phyto sanitary and other Indian regulatory submissions.
• Support internal compliance checks and readiness for regulatory inspections at plants and warehouses.
• Prepare and manage regulatory and technical docs for exports across EU, USA, UK, GCC, ASEAN and other markets.
• Develop and review technical docs: PDS, Allergen Statements, Certificates of Composition, Manufacturing Process Flow Diagrams, SDS.
• Prepare and maintain DMFs and regulatory dossiers in accordance with ICH guidelines (CTD and A-CTD).
• Coordinate documentation and submissions for animal health product registrations across international regions.
• Manage certification programs such as HALAL, KOSHER, Non-GMO, ISO, FSSC, HACCP.

Skills

Regulatory compliance

Documentation management

Audit coordination

Liaison with regulatory bodies

ICH guidelines

Job description

Roles & Responsibilities:

• 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.

Key Competencies & Behavioral Attributes:

• Highly reliable, self-driven, and adaptable to dynamic regulatory environments.
• Strong interpersonal and communication skills with the ability to collaborate across functions and sites.
• Demonstrates high standards of integrity, professionalism, and ethical conduct.
• Detail-oriented with excellent documentation skills and the ability to manage multiple priorities and timelines effectively.