Senior Director, Global Regulatory Lead – Biologics

Hugel Aesthetics

. Own the global regulatory strategy for the botulinum toxin and biologics portfolio across the U.S., Korea, Europe, Canada, Australia, and Asia-Pacific .

Posted 9/29/2026full-timeIrvine • California • United StatesSenior💰 $235,000 - $265,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive regulatory affairs expertise with a focus on biologics, particularly in leading global approvals and developing regulatory strategies for international markets. Proficient in collaborating with cross-functional teams and engaging with health authorities to drive lifecycle management and geographic expansion.

Highest-signal resume keywords

Regulatory Affairs ExperienceBiologics DevelopmentFDA Biologics/BLA ExperienceRegulatory Due DiligenceKorean Language Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Global Regulatory StrategyBotulinum Toxin Regulatory ExperienceCMC StrategyLifecycle ManagementHealth Authority NegotiationsInternational Market StrategyRegulatory SubmissionsBiologics ApprovalsMedical Aesthetics ExperienceRegulatory Compliance

Soft Skills

LeadershipCollaborationCommunicationNegotiation

Industry Keywords

BiologicsRegulatory AffairsHealth AuthoritiesM&ADue DiligenceClinical TeamsManufacturingQuality AssuranceMarket ExpansionKorea

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

12+ years of progressive regulatory affairs experience with substantial biologics development and registration experience
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
Strong FDA biologics/BLA experience
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
Direct botulinum toxin regulatory, CMC, and lifecycle experience preferred
Recent approvals spanning multiple major markets preferred
Experience with medical aesthetics indications and competitive landscape preferred
Experience working directly with Korean R&D, CMC, Manufacturing, Quality, and Regulatory teams preferred
Professional or fluent Korean language skills preferred
International travel, including frequent trips to Korea, required

Benefits

Comp & perks

Incentive compensation may be included in total cash compensation
Equal opportunity and inclusive work environment