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Senior Director, Regulatory Strategy & Policy

Job in Boston, Suffolk County, Massachusetts, 02108, USA
Listing for: Galderma
Full Time position
Listed on 2026-08-07
Job specializations:
  • Business
    Regulatory Compliance Specialist
Job Description & How to Apply Below

Galderma Regulatory Affairs Leader

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.

Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future.

Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold 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,…
Position Requirements
10+ Years work experience
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