Global Regulatory Strategy Leader - Therapeutic Dermatology

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

Benefits offered by this job

Medical, dental and vision coverage

401(k) with employer match

Paid time off

Annual incentive program

Job summary

Galderma Research & Development, LLC is seeking a strategic leader to head Global Regulatory Affairs for the Therapeutic Dermatology portfolio. You will drive regulatory strategy, manage interactions with the FDA and EU authorities, and coordinate lifecycle activities across R&D, Operations, and Regions.

The role requires 15+ years in regulatory strategy in biotech, strong FDA policy knowledge, and proven global leadership.

Qualifications

• 15+ years’ experience of regulatory strategy in biological/biotechnology spaces with direct FDA interactions.
• Strong FDA regulatory policy expertise; global/regional leadership experience.
• Excellent communication and leadership skills in a global, cross-functional environment.

Responsibilities

• Lead global regulatory strategy for the TD portfolio including interaction with US FDA and EU authorities.
• Oversee lifecycle activities: licenses maintenance, changes coordination with R&D, Global Ops and Regions.
• Manage outside service providers and regulatory assessments of new opportunities (R&D candidates, BD).
• Establish regulatory strategy and manage health authority consultations and dossier approvals for Nemluvio and inline assets.
• Drive regulatory intelligence and ensure compliance with new regulations and requirements.

Skills

FDA regulatory policy

Global/regional leadership

Executive presence

Verbal & written communication

Education

BSc/MSc/PhD in scientific field or PharmD

Job description

Galderma Research & Development, LLC is seeking a strategic leader to head Global Regulatory Affairs for the Therapeutic Dermatology portfolio. You will drive regulatory strategy, manage interactions with the FDA and EU authorities, and coordinate lifecycle activities across R&D, Operations, and Regions.

The role requires 15+ years in regulatory strategy in biotech, strong FDA policy knowledge, and proven global leadership.