Global Head of Therapeutic Dermatology Regulatory Strategy

About the role

The successful candidate will lead the strategy and drive the registration and maintenance of Galderma's Therapeutic Dermatology (TD) portfolio in accordance with global regulatory requirements and international quality standards. This includes managing the team working on Global Regulatory Affairs activities for the Company portfolio of Drug products (Nemluvio, Inline portfolio and any new project).

Responsibilities

• 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 filings 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)

Qualifications

• 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

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.

Compensation

The target base salary range for this role is $270,000-$380,000 per year. This range reflects the anticipated compensation for the role. Where pay falls within 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 an annual short-term and long-term incentive program, 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.