Global Regulatory Strategy Lead, Therapeutic Dermatology

Galderma; Boston (MA); On-site; USD 270,000 - 380,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan with employer match

Incentive program

Job summary

Galderma seeks an experienced Senior Regulatory Affairs Leader to drive regulatory strategy for its Therapeutic Dermatology portfolio, coordinating global interactions with FDA and other health authorities. The role oversees lifecycle management, new indications, and geographic expansion, with responsibility for external providers and regulatory intelligence.

This leadership position requires 15+ years in regulatory strategy within biologics/biotechnology, advanced science degrees, and strong

Qualifications

• 15+ years’ experience of regulatory strategy in biological/biotechnology spaces, including direct interactions with FDA and global experience.
• BSc, MSc, or Doctorate in Scientific discipline or a pharmacist.
• Strong FDA regulatory policy expertise is a plus.
• Experience leading in a global environment with ability to influence and motivate a team.
• Excellent verbal and written communication in a global, cross-functional setting.

Responsibilities

• Establish regulatory strategy and manage consultations with Health Authorities.
• Lead HA development interactions and filings globally for Nemluvio and inline assets.
• Drive lifecycle management and geographic rollout of products in key markets.
• Provide regulatory input to development documents (clinical, non-clinical, CMC).
• Oversee external service providers and regulatory intelligence activities.

Skills

Regulatory strategy

FDA regulatory policy

Executive presence

Global leadership

Communication skills

Education

Science degree

Job description

Galderma seeks an experienced Senior Regulatory Affairs Leader to drive regulatory strategy for its Therapeutic Dermatology portfolio, coordinating global interactions with FDA and other health authorities. The role oversees lifecycle management, new indications, and geographic expansion, with responsibility for external providers and regulatory intelligence.

This leadership position requires 15+ years in regulatory strategy within biologics/biotechnology, advanced science degrees, and strong