Associate - Regulatory & Compliances - Personal Care

3 days ago

Mumbai, India HI Talent Full time

Lower Parel, MumbaiReports to: Lead Manager Regulatory & ComplianceTLDR:ONLY people from Personal Care regulatory apply please.Key Requirements: - Prior experience of at least 3 years into Personal Care regulatory only- Domestic regulatory experience is mandatory- Knowledge of the Drugs and Cosmetics Act is mandatory.Job Summary:The Regulatory Executive (Personal Care) will ensure compliance of cosmetic and personal care products with all applicable laws and regulations, including the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, and related FDA requirements. The role involves managing product registrations, approvals, and documentation while supporting cross-functional teams in launching compliant products in the Indian and international markets.Key Compliance:- Ensure all cosmetic and personal care products comply with the Drugs & Cosmetics Act and Rules, including Schedule S, Q, and related labelling requirements.- Prepare and review product dossiers for submission to FDA and other authorities.- Track updates to Indian and international cosmetic regulations and communicate relevant changes to stakeholders.- Verify product formulations, ingredient lists, and claims to ensure they meet regulatory standards.- Liaise with external consultants and government departments for product approvals, notifications, and renewals.Licensing & Documentation:- Apply for and maintain Cosmetic Manufacturing, Import, and Marketing Licenses (Form 32/33).- Maintain accurate documentation of regulatory submissions, license renewals, and correspondence with authorities.- Support in FDA site inspections and assist in responding to audit queries or compliance observations.- Coordinate with Quality and Production teams to ensure adherence to GMP guidelines for cosmetics.Labelling & Claims Compliance:- Review and approve product labels and artworks for compliance with labeling regulations under the Drugs & Cosmetics Rules, Legal Metrology Act, and other applicable laws.- Validate product claims (e.g., dermatologically tested, paraben-free, etc.) to ensure they are substantiated and within regulatory boundaries.Stakeholder Collaboration:- Work closely with R&D, Marketing, and Quality Assurance teams to support compliant product development and launches.- Act as the regulatory point of contact for any product-related or labelling queries.Training & Awareness:- Conduct periodic internal sessions on cosmetic regulatory updates and compliance requirements.- Promote awareness of product safety, labelling standards, and regulatory obligations across Bachelors/Masters degree in Pharmacy, Cosmetic Technology, Chemistry, or related field.- 1-3 years of experience in Regulatory Affairs (Cosmetics / Personal Care).- Strong understanding of Drugs & Cosmetics Act and Rules, BIS Standards, and FDA procedures.- Experience in label and artwork compliance review.- Detail-oriented with strong documentation and communication skills.Key Performance Indicators (KPIs):- Timely submission and renewal of cosmetic licenses and approvals.- Zero major non-compliances during audits and inspections.- Accuracy of product labelling and claim validations.- Regulatory readiness and adherence to changing guidelines. (ref:iimjobs.com)

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