Regulatory Affairs Manager
Core
Lead end-to-end regulatory strategy and compliance for cosmetic, OTC, and general product portfolios across domestic and international markets.
Role type
Senior Regulatory Affairs Manager
Builds
Compliant product launches and lifecycle management for CPG brands
Domain
Consumer Packaged Goods (CPG), Cosmetics, OTC Drugs
Required skills
Regulatory strategy, FDA/MoCRA/Health Canada/EU/UK regulations, OTC drug listing and registration, change control, market entry strategy, competitive intelligence, SOP development
Preferred skills
Cross-functional partnership, complex requirement translation, project management
Technologies
None stated
Responsibilities
Lead regulatory review of new product launches; Own OTC drug product listing and renewals; Oversee domestic and international registration; Support post-market activities and change control; Monitor and interpret evolving regulatory requirements; Lead regulatory market entry strategy; Provide competitive intelligence reporting; Respond to regulatory inquiries; Partner with internal and external teams; Develop and maintain regulatory SOPs
Seniority
Senior, hands-on IC