Supervisor, Reg Affairs
Core
Manages regulatory programs, policies, and procedures to ensure commercial and post-market compliance for human drug, medical device, and cosmetic portfolios.
Role type
Senior IC regulatory affairs supervisor
Builds
Regulatory workflows, labeling approvals, and database integrity for private label and commercialized products
Domain
Pharmaceutical and medical device regulatory compliance
Required skills
FDA compliance policy guides, 21 CFR Part 11, USP standards, Kallik/FACTS/Veeva Vault QMS, eDRLS/I4I/A4L software, SOP development, cross-functional consensus building
Preferred skills
Private label experience, clinical medical safety collaboration, defect root-cause analysis
Technologies
Kallik, FACTS, Veeva Vault QMS, eDRLS, I4I/A4L
Responsibilities
Supervise labeling and listing specialists; oversee drug listing activities and UDI submissions; resolve complex packaging/labeling deviations; update Standard Operating Procedures; act as regulatory liaison between Quality, Packaging, and external vendors.
Seniority
Senior, hands-on IC with team supervision