Director, Head of Global Nemluvio Regulatory Strategy

Galderma•Boston, MA

19h•$200,000 - $265,000•Hybrid

About The Position

Galderma is a leading company in the dermatology sector, operating in approximately 90 countries. We offer innovative, science-based products and services across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our inception in 1981, our focus has been on skin health, providing superior outcomes for individual consumers and patients in partnership with healthcare professionals. We are committed to advancing dermatology for every skin story. We seek individuals who are results-oriented, eager to learn, and possess a positive attitude, combining initiative with teamwork. Passion for making a meaningful impact on consumers, patients, and healthcare professionals is essential. We aim to empower employees and foster their personal growth while meeting business needs. Diversity, dignity, privacy, and personal rights are respected across the company. At Galderma, we provide opportunities for challenging work experiences and significant impact, supporting our ambition to be the world's leading dermatology company.

Requirements

Knowledge 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 bodies.
Experience interfacing with regulatory agencies and skill at implementing successful global regulatory strategies.
Experience 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 team.
Experience with international project management.
Focused on effective delivery of objectives, even when working with tight deadlines.
Ability to identify opportunities/major issues and to communicate impact.
Demonstrated ability to deal with rapid change.

Responsibilities

Leads 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.
Accountable for global regulatory strategies and global submission plans for Atopic Dermatitis (AD), Prurigo Nodularis (PN) and any newly identified indications.
Leads Nemluvio Global Regulatory Team, establishing team goals, norms, responsibilities, and communication plans.
Accountable for US regulatory strategies for all indications in coordination with US Regulatory Affairs Team.
Primary contact for FDA.
Identify and assess risks associated with product development and recommend strategies to mitigate these risks.
Core member of Nemluvio Global Project Team, provide regular updates to leadership, Nemolizumab product strategy team, and commercial teams.
Ensure strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as needed.