Senior Director, Global Regulatory Lead – Biologics
About The Position
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.
Requirements
- 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 Haves
- 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.
Responsibilities
- 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.
Benefits
- Total cash compensation could include base salary and incentive compensation.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
