About this opportunity
Galderma Research & Development, LLC lists this Global Head of Therapeutic Dermatology Regulatory Strategy opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our 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 Leads 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. 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, including direct interactions with US FDA and EU authorities Lifecycle activities of approved portfolio: maintenance of licenses, coordination with R&D, Global Operations, Global Product Strategy and Regions for any required changes to approved portfolio. 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.
Key Responsibilities
Accountable for the team working on Global Regulatory Affairs activities for the Company portfolio of Drug products (Nemluvio, Inline portfolio and any new project).
New development projects prior to approval, including direct interactions with US FDA and EU authorities.
Lifecycle activities of approved portfolio: maintenance of licenses, coordination with R&D, Global Operations, Global Product Strategy and Regions for any required changes to approved portfolio.
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).
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.
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions 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 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 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.
Eligible to participate in an annual short-term and long-term incentive program, subject to plan terms and eligibility requirements.
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.