Global Regulatory Strategy Lead – Therapeutic Dermatology

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

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Paid time off

Job summary

Galderma is seeking a seasoned Regulatory Affairs leader in the United States to direct strategy and regulatory submissions for Therapeutic Dermatology. You will coordinate with FDA and global authorities, guide lifecycle management, and drive regulatory intelligence across markets.

You will oversee outside partners, manage timelines, and ensure compliance while supporting product development in a fast-changing dermatology landscape.

Qualifications

• 15+ years’ experience of regulatory strategy in biological / biotechnology spaces, including direct interactions with FDA as well as a global experience.
• Strong FDA regulatory policy expertise a plus.
• Prior experience managing in a global environment with ability to lead, influence and motivate a team.

Responsibilities

• Establish regulatory strategy, manage consultations with Health Authorities, dossier preparation and approval for Nemluvio, inline assets and innovative development projects.
• Lead and directly manage HA development interactions and fillings globally.
• Lead and drive lifecycle management (new indications) and geographic rollout of new products in relevant markets.
• Secure maintenance and regulatory compliance of TD commercial products.
• Lead regulatory intelligence activities to assure compliance with new regulations and recommendations.

Skills

Regulatory strategy

FDA interactions

Leadership

Cross-functional collaboration

Communication

Education

BSc, MSc, or Doctorate in Scientific discipline or pharmacist

Tools

RIMS

Job description

Galderma is seeking a seasoned Regulatory Affairs leader in the United States to direct strategy and regulatory submissions for Therapeutic Dermatology. You will coordinate with FDA and global authorities, guide lifecycle management, and drive regulatory intelligence across markets.

You will oversee outside partners, manage timelines, and ensure compliance while supporting product development in a fast-changing dermatology landscape.