Regulatory Manager

Job Description

Roles and Responsibilities Manage regulatory affairs for domestic and international markets, ensuring compliance with FDA, ICH, EU regulations. Prepare dossiers for new product approvals, including artwork design and labeling requirements. Coordinate with cross-functional teams for formulation development, export documentation (DGFT), and licensing processes. Ensure legal metrology compliance by managing product registrations and maintaining accurate records. Provide guidance on regulatory matters to internal stakeholders and external partners. Handle regulatory documentation and submissions for Nutraceutical and Cosmetic products (domestic & export). Prepare dossiers, technical files, and product registrations as per domestic (FSSAI, CDSCO & Ect.) and international regulations. Ensure products comply with all legal and regulatory requirements of India and specific export markets. Regulatory handling and submission experience for Canada, USA, and European Union (EU) is mandatory. Review product labels, artworks, and marketing materials to ensure regulatory compliance. Liaison with internal departments (R&D, QC, QA, Marketing) for compiling regulatory documents. Maintain up-to-date knowledge of changing regulations in export markets. Desired Candidate Profile 2-10 years of experience in pharmaceutical industry with expertise in drug regulatory affairs. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree (M.Pharma). Strong understanding of FSSAI guidelines and regulations governing food supplements/nutraceuticals.