Director, Head of Global Nemluvio Regulatory Strategy

Galderma • Boston, MA

21h • Hybrid

About The Position

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.

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.
• External applicants must be eligible to work in the United States.

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.

Benefits

• medical, dental, and vision coverage
• a 401(k) plan with employer match
• paid time off
• other benefits, subject to eligibility and applicable plan terms
• competitive compensation
• annual incentive opportunities
• comprehensive benefits
• meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed