Senior Director, Global Regulatory Lead - Biologics

Senior Director, Global Regulatory Lead - Biologics Global Regulatory Affairs • Irvine, California • Frequent travel to Korea About this role Hugel Aesthetics is looking for a Senior Director, Global Regulatory Lead (GRL) - Toxin & Biologics to own our global regulatory strategy for botulinum toxin and related biologics - from early development and due diligence through global approvals and lifecycle management. This is an enterprise-level role for a regulatory leader who has personally led health authority negotiations and delivered global biologic approvals. You'll partner daily with R&D, Clinical, CMC, Manufacturing, Quality, Medical, Commercial, and regional regulatory teams across the U.S., Korea, and other global markets - and represent Global Regulatory Affairs directly to health authorities and to our senior leadership and governance committees. What you'll do • Own the global regulatory strategy for our 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 (FDA, Korean MFDS, EU authorities, Health Canada, TGA, and others). • Present regulatory strategy, risks, and recommendations directly 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. What you bring • 12+ years of progressive regulatory affairs experience, with substantial biologics development and registration experience. • A proven, recent track record of leading global biologic approvals - ideally botulinum toxin or other complex injectable biologics. • Extensive, hands-on experience leading face-to-face health authority meetings, not just submission coordination. • Strong FDA biologics/BLA experience plus experience building regulatory strategy for international markets. • Substantial regulatory due diligence experience supporting licensing, M&A, or partnership decisions. • Bachelor's degree in a scientific, medical, pharmaceutical, or regulatory field (advanced degree preferred). Nice to have • Direct botulinum toxin regulatory, CMC, and lifecycle experience. • Recent approvals spanning multiple major markets (U.S., EU, Korea, Canada, Australia, Asia-Pacific). • Experience with medical aesthetics indications and the competitive landscape. • Experience working directly with Korean R&D, CMC, Manufacturing, Quality, and Regulatory teams. • Professional or fluent Korean language skills. Travel Based in Irvine, CA, with international travel required - including frequent trips to Korea to support development programs, CMC/manufacturing strategy, and health authority preparation. Compensation The most likely base pay range for this position is $235,000 to $265,000 per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual's exact level of compensation. Base salary is only one element of employee compensation at Hugel Aesthetics. The total cash compensation could include base salary and incentive compensation.