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 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, a...