Hugel Aesthetics

Manager

• Serve as the U.S.-based Quality lead for Hugel's cosmetic portfolio
• Oversee third-party manufacturers and CDMOs
• Act as the primary Quality interface with cosmetic manufacturers for product complaints, quality issues, and investigations
• Lead development and lifecycle management of global cosmetic Quality SOPs and policies within Veeva
• Review shipping, transportation, and receipt documentation for biologic products received in the U.S. from Korea before release into U.S. distribution
• Coordinate U.S. biologic product complaints with manufacturing and Quality teams in Korea through investigation closure
• Support U.S. cosmetic regulatory registration and compliance activities
• Partner with Regulatory Affairs, Supply Chain, Commercial, Product Development, and Korea Quality teams to support global growth
• Support quality audits and manufacturer oversight through occasional travel

Senior Manager, Global Quality – Cosmetics

Compliance

• Own the global regulatory strategy for the botulinum toxin and biologics portfolio across the U.S., Korea, Europe, Canada, Australia, and Asia-Pacific
• Lead face-to-face negotiations and briefings with global health authorities, including FDA, Korean MFDS, EU authorities, Health Canada, and TGA
• Present regulatory strategy, risks, and recommendations to senior leadership and governance boards
• Partner with R&D and Clinical teams in Korea and the U.S. from early development through global submissions
• Guide CMC, manufacturing, and comparability strategy for post-approval changes and lifecycle initiatives
• Serve as the senior regulatory voice on business development and due diligence for biologic assets and transactions
• Drive lifecycle management and geographic expansion for marketed products, including new indications and markets
• Collaborate with R&D, Clinical, CMC, Manufacturing, Quality, Medical, Commercial, and regional regulatory teams

Senior Manager, Global Quality – Cosmetics

Senior Director, Global Regulatory Lead – Biologics