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Senior Director, Regulatory Strategy & Policy

Galderma
United Statesfull_timeVerifiedPosted 14 Aug 2026
💰 $320,000/yr($240,000/yr$320,000/yr)

About the role

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

The Opportunity

This role leads US regulatory policy and advocacy efforts to support the advancement and lifecycle management of Galderma portfolio. The position plays a critical role in shaping the evolving US regulatory environment by influencing key policy decisions and ensuring Galderma is well-positioned to anticipate and respond to regulatory change.

Working across global and US-based teams, this role develops science-driven policy strategies, engages with regulatory agencies and external stakeholders, and supports enterprise-level advocacy priorities. The role offers strong visibility, professional growth, and the change to make a meaningful impact for patients, consumers and Galderma.

Key Responsibilities

  • Provide interpretation and advice on new US legislation, guidelines and policies for assigned topics in support of Galderma portfolio.

  • Collaborate with internal teams to develop and execute regulatory policy strategies in the US.

  • Support Galderma's strategy for US engagement and maintain links with key external stakeholders and networks including regulatory agencies and trade associations.

  • Interact with key regulatory agencies, governments and trade associations on assigned topic areas.

  • Liaise with other GRA staff, US government affairs staff, R&D functions, and other internal stakeholders to support development of aligned Galderma positions.

  • Lead global regulatory policy and advocacy strategy for select enterprise-level policy priorities.

  • Lead asset-specific global regulatory policy and advocacy strategy for select priority assets and in select priority markets.

  • Support responses to regulatory intelligence queries from R&D partners.

  • Serves as the U.S. FDA Regulatory Affairs strategic partner to the Global Heads of Regulatory Strategy (Therapeutic Dermatology, DS and IA), providing strategic leadership on FDA engagement, regulatory submissions, and Health Authority interactions to ensure alignment of U.S. regulatory strategy with global development objectives and successful product development and lifecycle management.

  • Leads the development of U.S. regulatory strategy for assigned projects and programs (from first-in-human through post-marketing), ensuring alignment with FDA regulations, guidance, and expectations, as documented in Global Regulatory Strategy Documents.

  • Represents Global Regulatory Affairs (GRA) on core development and cross-functional project teams, collaborating with regional and global leaders to ensure a unified regulatory approach that supports FDA interactions and global commercial strategy.

  • Shapes the regulatory strategy for INDs, NDAs, BLAs, supplemental applications, FDA meeting packages (e.g., Type A, B, and C meetings), responses to FDA information requests, and other Health Authority communications.

  • Provides strategic regulatory leadership and guidance to cross-functional teams by addressing complex regulatory issues, identifying innovative solutions, and ensuring consistent communication across Global Regulatory Affairs and project teams.

  • Counsels and advises GRA leadership on U.S. Regulatory Affairs strategies, FDA requirements, regulatory risks, and engagement strategies to support successful development and lifecycle management.

  • Ensures regulatory strategies support business objectives while maintaining compliance with FDA regulations, applicable U.S. laws, and global regulatory requirements.

  • Partners with the Global Heads of Regulatory Strategy to develop integrated global regulatory strategies while serving as the primary lead for all U.S. FDA-specific regulatory matters.

  • Monitors and interprets emerging U.S. legislation, FDA regulations, guidance documents, and regulatory policy changes, proactively advising project teams and adapting regulatory strategies to evolving requirements.

  • Supports Galderma's regulatory policy and advocacy strategy by partnering with U.S. Government Affairs, trade associations, and external stakeholders to advance regulatory priorities and represent the company's interests with the FDA and other relevant organizations.

  • Leads or contributes to e

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Company

Galderma

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