Senior Director, Global Regulatory Lead – Biologics

We're Hiring: Senior Director, Global Regulatory Lead – Biologics

Global Regulatory Affairs • Irvine, California • Frequent travel to Korea

About Hugel

Founded in 2001, Hugel is a South Korea–based global leader in medical aesthetics, specializing in the development and commercialization of botulinum toxin, hyaluronic acid fillers, skin boosters, threads, and biocosmetics. Over the past two decades, Hugel has built a strong global footprint, with commercial presence in approximately 70 countries and operations across nine international subsidiaries.

Leveraging strong global momentum, Hugel Aesthetics was formed as the Company's dedicated North American business unit, established to lead commercialization in the United States, Canada, and Australia. Backed by Hugel's global scale and expertise, Hugel Aesthetics is a well-resourced, growth-oriented organization focused on expanding access to Letybo and establishing a strong, long-term presence in medical aesthetics.

Company Culture

We are building our U.S. organization from the ground up, creating a culture that is intentionally different from traditional, highly layered companies. This is a rare opportunity to join at an early stage and help shape not only the business, but the way we work, lead, and grow together.

Our culture is rooted in high ownership, collaboration, and the belief that every voice matters. We value people who bring ideas, take initiative, and want a true seat at the table. In this environment, individuals are empowered to make an impact, move with agility, and help build what comes next.

Above all, we are deeply customer focused. We are committed to earning trust, building long-term partnerships, and delivering meaningful value through science, transparency, and integrity.

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.

Hugel Aesthetics is an equal opportunity employer.

We are committed to creating an inclusive environment for all employees and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other legally protected status.