Regulatory Affairs Specialist
Core
Manage U.S. FDA OTC drug regulatory compliance strategy, labeling, and supply chain obligations for antiseptic, antimicrobial, and veterinary products.
Role type
Regulatory Affairs Specialist (OTC Drugs)
Builds
Compliant OTC drug products and marketing materials for the U.S. market
Domain
Pharmaceuticals / Regulatory Compliance
Deliverable
client delivery
Required skills
U.S. FDA regulatory compliance, 21 CFR interpretation, OTC monograph analysis, labeling and claims review, third-party logistics compliance, state licensing coordination, FDA inspection management, regulatory intelligence
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage U.S. FDA OTC drug compliance strategy and submissions; Review and approve OTC drug labeling, claims, and marketing text; Evaluate compliance obligations for third-party logistics providers and contract manufacturers; Assess state-level wholesale or distributor licensing requirements; Act as primary lead during U.S. FDA inspections and audits; Monitor changes in U.S. FDA OTC regulations and provide advisory support
Seniority
Mid-to-Senior level (5–10+ years experience)
