Strategic Leader Therapeutic Dermatology Regulatory

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

Job summary

Galderma Laboratories seeks a seasoned leader to drive regulatory strategy for its Therapeutic Dermatology portfolio, coordinating global submissions and lifecycle activities. You will interact directly with FDA and global authorities, guide development programs, and oversee external providers to ensure regulatory excellence across markets.

The role requires 15+ years in regulatory strategy within biotech, with strong leadership and cross-functional collaboration skills, and a track record of

Qualifications

• 15+ years' experience in regulatory strategy within biological/biotech spaces with direct FDA interactions.
• Strong leadership and ability to motivate a global team.
• Experience interacting with health authorities globally and managing regulatory submissions.

Responsibilities

• Establish regulatory strategy and manage consultations with Health Authorities.
• Lead HA development interactions and fillings globally.
• Drive lifecycle management and geographic rollout of new products in relevant markets.
• Ensure regulatory compliance of TD commercial products.
• Provide regulatory input to development activities and assess risks.
• Support Operations Projects and change controls with regulatory insights.
• Forecast scientific writing activities for regulatory documentation.
• Lead regulatory intelligence to ensure compliance with evolving regulations.
• Manage RIMS and maintain archives of regulatory records.
• Oversee outsourcing providers for regulatory work.

Skills

Regulatory strategy

Global regulatory affairs

FDA interactions

Leadership

Project management

Education

BSc/MSc or Doctorate in scientific discipline or pharmacy

Job description

Galderma Laboratories seeks a seasoned leader to drive regulatory strategy for its Therapeutic Dermatology portfolio, coordinating global submissions and lifecycle activities. You will interact directly with FDA and global authorities, guide development programs, and oversee external providers to ensure regulatory excellence across markets.

The role requires 15+ years in regulatory strategy within biotech, with strong leadership and cross-functional collaboration skills, and a track record of