Global Head of Therapeutic Dermatology Regulatory Strategy

Galderma•Boston, MA

5d•$270,000 - $380,000•Onsite

About The Position

Galderma is seeking a Global Head of Therapeutic Dermatology Regulatory Strategy to 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 role is accountable for the team working on Global Regulatory Affairs activities for the Company portfolio of Drug products (Nemluvio, Inline portfolio and any new project). This includes new development projects prior to approval, lifecycle activities of approved portfolio, managing service providers, and leading regulatory assessment of new opportunities. The position is a critical member of TD governing committees and leadership teams, playing a key role in leading the global regulatory strategy of major transformative Galderma programs.

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.
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.

Nice To Haves

Strong FDA regulatory policy expertise a plus

Responsibilities

Manage and support the Therapeutic Dermatology Regulatory Strategy team to drive 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 by ensuring strategic regulatory input is provided to key development activities and documents, identifying and assessing risks, and recommending mitigation strategies.
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.