Regulatory Affairs Associate

Independent Recruitment Consultant (freelancer); Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Independent Recruitment Consultant (freelancer) in Bengaluru seeks a regulatory affairs professional to manage end-to-end compliance for herbal extracts, intermediates, and finished products within domestic markets in India.

You will coordinate AYUSH, FSSAI, and other regulatory requirements, prepare licensing documents, support audits, and liaise between plants and regulatory bodies across compliant manufacturing sites.

Qualifications

• Experience in regulatory compliance for herbal extracts, intermediates, and finished products.
• Knowledge of AYUSH, FSSAI, and Schedule M, T, and related guidelines.
• Proficient in preparing licensing documents and regulatory submissions.
• Experience with DMFs, CTD/ACD formats and international dossiers.
• Experience in audits and regulatory inspections at plants and warehouses.

Responsibilities

• Coordinate documentation for domestic and export regulatory submissions across multiple geographies.
• Prepare and maintain regulatory documentation and licenses.
• Liaise with regulatory bodies and support third-party audits.
• Ensure labeling and artwork compliance per metrology guidelines for cosmetics and nutraceuticals.
• Support certifications such as HALAL, ISO, HACCP, and other quality/compliance programs.

Skills

Regulatory affairs

Documentation management

Audit readiness

GMP compliance

Cross-functional coordination

Job description

• 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.