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 directions for use.
Support internal teams during relabeling of imported OTC products for the U. S. market
3. Third-Party & Sup...