Executive / Senior Executive - Regulatory Affairs

Roles & Responsibilities:

Regulatory Compliance Herbal Extracts, Intermediates & Finished Goods:

• 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.