Regulatory Affairs Specialist

Galaxy Surfactants Limited
Job description
📍 Mumbai, Maharashtra
💼 Full time
💰 Competitive
📅 Posted 30/05/2026

Job description

Key Responsibilities: 1 . U.S. FDA & OTC Drug Regulatory Compliance: Own and manage U.S. FDA OTC drug compliance strategy for all relevant products, including antiseptic, antimicrobial, and veterinary OTC applications where applicable. Ensure Drug Establishment Registration, NDC Labeler Code management, and Drug Listing submissions are completed accurately and maintained on an ongoing basis. Interpret and apply 21 CFR Parts 201, 210, 211, and 330, including OTC monographs and labeling requireme…

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