Senior Director, Regulatory Strategy & Policy

Galderma•Boston, MA

1d•Onsite

About The Position

Galderma is a leading company in the dermatology sector, operating in approximately 90 countries. We offer innovative, science-based products and services across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since 1981, our focus has been on skin health, addressing individual needs with superior outcomes in partnership with healthcare professionals. We are looking for individuals who are results-oriented, eager to learn, and bring a positive attitude, combining initiative with teamwork. Passion for making a meaningful difference for consumers, patients, and healthcare professionals is essential. We aim to empower employees and promote personal growth while meeting business needs. Diversity and respect are core values at Galderma. We offer opportunities for challenging work experiences and significant impact. This role is responsible for leading US regulatory policy and advocacy efforts to support Galderma's portfolio advancement and lifecycle management. The position is crucial in shaping the US regulatory environment by influencing policy decisions and ensuring Galderma can anticipate and respond to regulatory changes. Working with global and US teams, this role involves developing science-driven policy strategies, engaging with regulatory agencies and external stakeholders, and supporting enterprise-level advocacy priorities. The role offers high visibility, professional growth, and the chance to make a meaningful impact on patients, consumers, and Galderma.

Requirements

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
External applicants must be eligible to work in the United States.

Nice To Haves

Make Derm/aesthetics preferred

Responsibilities

Provide interpretation and advice on new US legislation, guidelines, and policies for assigned topics in support of Galderma's 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 the 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.
Serve 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.
Lead 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.
Represent 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.
Shape 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.
Provide 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.
Counsel and advise GRA leadership on U.S. Regulatory Affairs strategies, FDA requirements, regulatory risks, and engagement strategies to support successful development and lifecycle management.
Ensure regulatory strategies support business objectives while maintaining compliance with FDA regulations, applicable U.S. laws, and global regulatory requirements.
Partner 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.
Monitor and interpret emerging U.S. legislation, FDA regulations, guidance documents, and regulatory policy changes, proactively advising project teams and adapting regulatory strategies to evolving requirements.
Support 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.
Lead or contribute to enterprise-wide and asset-specific regulatory policy and advocacy initiatives that support Galderma's long-term strategic objectives.
Provide 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.
Manage regulatory project plans and timelines to ensure FDA submissions, reviews, regulatory milestones, and post-approval commitments are appropriately prioritized and delivered on schedule.
Drive continuous improvement of Therapeutic Area Regulatory Affairs processes by incorporating lessons learned from FDA interactions, inspections, and evolving regulatory expectations.
Provide leadership and mentorship to Regulatory Affairs team members while fostering collaboration, scientific excellence, and regulatory best practices across the organization.