Senior Director, 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 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, 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 enterprise-wide and asset-specific regulatory policy and advocacy initiatives that support Galderma's long-term strategic objectives.
• Provides regulatory intelligence and strategic insights to R&D, Commercial, Medical Affairs, and other cross-functional stakeholders regarding changes in the U.S. regulatory landscape and their potential impact on the portfolio.
• Manages regulatory project plans and timelines to ensure FDA submissions, reviews, regulatory milestones, and post-approval commitments are appropriately prioritized and delivered on schedule.
• Drives continuous improvement of Therapeutic Area Regulatory Affairs processes by incorporating lessons learned from FDA interactions, inspections, and evolving regulatory expectations.
• Provides leadership and mentorship to Regulatory Affairs team members while fostering collaboration, scientific excellence, and regulatory best practices across the organization.

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 edermatology and aesthetics
• Experience/familiarity with biologics products and medical devices and make
• Derm/aesthetics preferred

Physical Requirements And Work Environment

This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required. Work environments and physical requirements may vary based on the requirements of the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

This job description describes the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities. Duties and responsibilities may be modified, added, or removed as necessary to meet business and organizational needs.

Compensation

The target base salary range for this role is $240,000-$320,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors.

In addition to base salary, this role is eligible to participate in annual short-term and long-term incentive programs, subject to plan terms and eligibility requirements.

Benefits

Galderma offers a competitive and comprehensive benefits program, including medical, dental, and vision coverage, a 401(k) plan with employer match, paid time off, and other benefits, subject to eligibility and applicable plan terms.

Work Authorization

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

What We Offer

At Galderma, you’ll be part of a purpose-driven organization committed to advancing dermatology and improving patient outcomes worldwide. We offer competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.

Next Steps

• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Don't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role, but your experience doesn't align perfectly with the qualifications listed, we encourage you to apply anyway!

If you are considering employment at Galderma, review our job postings at www.galderma.com/us/careers. Please be aware of fraudulent job offers and individuals falsely claiming to represent our Human Resources department. Our company will never request or offer payment, personal financial information, or sensitive data (such as Social Security numbers or bank details) during the early stages of recruitment. All legitimate communications from our HR team will come from official company email domains and follow our established hiring process.