Regulatory Affairs Specialist
ROLE DEFINITION & RESPONSIBILITIES
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…
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Galaxy Surfactants Limited is a leading manufacturer and supplier of specialty chemicals, primarily catering to the Home and Personal Care industry. The company develops, produces, and markets a wide range of surfactants, rheology modifiers, and other functional ingredients used in products like shampoos, conditioners, soaps, detergents, and cosmetics. They focus on sustainable chemistry and innovative solutions for a global clientele.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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