Director, U.S. Regulatory Strategy & Policy

Galderma; Boston (MA); On-site; USD 240,000 - 320,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with employer match

Paid time off

Job summary

Galderma is seeking a senior Regulatory Affairs and Policy leader to drive US regulatory policy and advocacy for the portfolio across Therapeutic Dermatology, DS and IA. The role interfaces with FDA, regulators, and external stakeholders to shape strategy from development through lifecycle management.

You will lead global and asset-specific regulatory policy initiatives, provide strategic direction to R&D, Commercial, and Medical Affairs, and mentor regulatory teams while ensuring compliance and

Qualifications

• 15+ years of experience in regulatory affairs/policy across the full medicines development lifecycle.
• Demonstrated experience in regulatory policy and advocacy within the US regulatory environment.
• Prior experience engaging with US regulatory agencies, government bodies, and industry/trade associations.
• Broad understanding of the US regulatory landscape, including key agencies and policymaking processes.
• Proven track record influencing regulatory policy and building coalitions within industry or public policy forums.
• Familiarity with regulatory policies around dermatology and aesthetics.
• Experience/familiarity with biologics products and medical devices.

Responsibilities

• Provide regulatory policy leadership across the US portfolio, shaping federal strategy and lifecycle management.
• Collaborate with internal teams to develop and execute regulatory policy strategies in the US.
• Support engagement with regulators and external stakeholders to advance regulatory priorities.
• Interact with regulatory agencies, governments, and trade associations on assigned topics.
• Lead global and asset-specific regulatory policy strategies for enterprise priorities and select markets.
• Serve as the US FDA Regulatory Affairs strategic partner to senior leaders, aligning US strategy with global development objectives.
• Develop and communicate regulatory strategy from early development through post-marketing.
• Represent GRA on cross-functional project teams to ensure unified regulatory approaches.
• Counsel leadership on regulatory risks, requirements, and engagement strategies.
• Monitor emerging US regulations and guidance to adapt strategies accordingly.

Skills

Regulatory affairs

Policy advocacy

US regulatory engagement

Stakeholder engagement

Cross-functional collaboration

Job description

Galderma is seeking a senior Regulatory Affairs and Policy leader to drive US regulatory policy and advocacy for the portfolio across Therapeutic Dermatology, DS and IA. The role interfaces with FDA, regulators, and external stakeholders to shape strategy from development through lifecycle management.

You will lead global and asset-specific regulatory policy initiatives, provide strategic direction to R&D, Commercial, and Medical Affairs, and mentor regulatory teams while ensuring compliance and