Director, Head of Global Nemluvio Regulatory Strategy

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.At Galderma, we actively give our teams reasons to believe in our bold 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 OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage indications, ensuring regulatory activities are executed in accordance with global regulatory requirements, corporate objectives, and agreed timelines. Accountable for the Global Regulatory Affairs team supporting nemolizumab and for driving successful regulatory outcomes across the product lifecycle.Key Responsibilities Accountable for global regulatory strategies and global submission plans for Atopic Dermatitis (AD), Prurigo Nodularis (PN) and any newly identified indicationsLeads Nemluvio Global Regulatory Team, establishing team goals, norms, responsibilities, and communication plansAccountable for US regulatory strategies for all indications in coordination with US Regulatory Affairs TeamPrimary contact for FDAIdentify and assess risks associated with product development and recommend strategies to mitigate these risksCore member of Nemluvio Global Project Team, provide regular updates to leadership, Nemolizumab product strategy team, and commercial teamsEnsure strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, and EU)10 years of experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodiesExperience interfacing with regulatory agencies and skill at implementing successful global regulatory strategiesExperience with documenting regulatory strategies in coordination with clinical plans and marketing objectives.Excellent team interaction skills along with demonstrated ability to work on a cross-functional teamExperience with international project managementFocused on effective delivery of objectives, even when working with tight deadlinesAbility to identify opportunities/major issues and to communicate impactDemonstrated ability to deal with rapid changePhysical Requirements and Work EnvironmentThis 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.This job description describes the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities. Duties and responsibilities may be modified, added, or removed as necessary to meet business and organizational needs.CompensationThe target base salary range for this role is $200,000-$265,000 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.BenefitsGalderma 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 AuthorizationThis role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.What We OfferAt Galderma, you’ll be part of a purpose-driven organization committed to advancing dermatology and improving patient outcomes worldwide. We offer competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.Next StepsIf your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring managerThe final step is a panel conversation with the extended teamDon't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role, but your experience doesn't align perfectly with the qualifications listed, we encourage you to apply anyway!If you are considering employment at Galderma, review our job postings at . Please be aware of fraudulent job offers and individuals falsely claiming to represent our Human Resources department. Our company will never request or offer payment, personal financial information, or sensitive data (such as Social Security numbers or bank details) during the early stages of recruitment. All legitimate communications from our HR team will come from official company email domains and follow our established hiring process.SummaryLocation: BostonType: Full time