Global Head of Therapeutic Dermatology Regulatory Strategy

Galderma•Boston, MA

4d•Hybrid

About The Position

Galderma is a leading company in the dermatology category, operating in approximately 90 countries. We offer an innovative, science-based portfolio of premium brands and services across the rapidly growing dermatology market, including Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our inception in 1981, we have been dedicated to skin health, meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. We believe that skin health shapes our lives and are committed to advancing dermatology for every skin story. We seek individuals who are results-oriented, embrace learning, and bring positive energy. Candidates should possess initiative, teamwork, and collaboration skills, and a passion for making a meaningful impact on consumers, patients, and healthcare professionals. We aim to empower employees and promote personal growth while meeting business needs. We foster diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we provide our teams with compelling reasons to believe in our ambitious goal of becoming the world's leading dermatology company. Joining us offers unparalleled opportunities for new and challenging work experiences and the chance to make a direct impact.

Requirements

15+ years’ experience of regulatory strategy in biological / biotechnology spaces, including direct interactions with FDA as well as a global experience.
BSc, MSc, or Doctorate in Scientific discipline or a pharmacist.
Strong FDA regulatory policy expertise a plus.
Prior experience managing in a global environment with ability to lead, influence and motivate a team.
Strong executive presence to interact with senior leadership.
Planning, organizing and time management skills.
Problem solving and analytical skills.
Ability to identify opportunities/major issues and to communicate impact.
Demonstrated ability to deal with rapid change.
Effective verbal and written communication skills in a global, cross-functional environment.
External applicants must be eligible to work in the United States.

Responsibilities

Leads the strategy and drives the registration and maintenance of Galderma's Therapeutic Dermatology (TD) portfolio in accordance with global regulatory requirements and international quality standards.
Accountable for the team working on Global Regulatory Affairs activities for the Company portfolio of Drug products (Nemluvio, Inline portfolio and any new project).
Manages the service providers in support of the function.
Leads and drives regulatory assessment of new opportunities (internal R&D candidates, and BD external opportunities).
Member of TD governing committees; member of GPV, GRA, & RDQA LT; extremely critical position in leading the Global regulatory strategy of major transformative Galderma programs such as Nemluvio across both biological regulations and drug regulations.
Manage and support the Therapeutic Dermatology Regulatory Strategy team to drive the following major activities: Establish regulatory strategy, manage consultations with Health Authorities, dossier preparation and approval for Nemluvio, inline assets and innovative development projects.
Lead and directly manage HA development interactions and fillings globally.
Lead and drive lifecycle management (new indications) and geographic rollout of new products in relevant markets.
Secure maintenance and regulatory compliance of TD commercial products.
Support new development projects: ensure strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as needed.
Identify and assess risks associated with product development and recommend strategies to mitigate these risks.
Drive regulatory support to all Operations Projects and change controls.
Provide accurate forecasting of scientific/medical writing activities.
Lead regulatory intelligence activities in Drugs and TD to assure compliance with new regulations, requirements and recommendations from relevant Authorities and regulatory bodies.
Support the Regulatory Information Management System (RIMS).
Maintain archive inventory of physical and electronic archives of all required records.
Lead and drive regulatory assessment of new opportunities (internal R&D candidates, BD external opportunities).
Accountable for management of outside service providers.