Regulatory Affairs Specialist

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 requirements.
• Assess regulatory pathways for new OTC ingredients, relabeled products, or imported OTC drugs

2. Labeling, Claims & Product Compliance

• Review and approve OTC drug labeling, claims, and marketing text for U.S. compliance.
• Ensure alignment with OTC monograph conditions, active ingredient concentration limits, intended use, warnings, and direct...