Senior Director – US Regulatory Strategy

🔥 0 minutes ago

🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Voisin Consulting Life Sciences (VCLS)

WebsiteLinkedInAll Job Openings

201 - 500 employees

From discovery to product launch and lifecycle managementAt VCLS (Voisin Consulting Life Sciences), regulatory science guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Starting early in the process, from discovery to the patient, VCLS assists innovators in designing optimized product development plans and regulatory strategies, combining the health ecosystem with commercial success. With a presence in seven locations across three continents and over 200 employees, VCLS serves a broad range of healthtech developers and their investors.Together, we accompany global stakeholders to expedite HealthTech products from discovery to patient access and beyond by bridging Science to Regulatory and Market Access strategies.

📋 Description

• Lead development and execution of US and global regulatory strategy for clients across all stages of development, with emphasis on late-stage development, registration, and lifecycle management. • Serve as regulatory lead for ADCs, bispecific/trispecific antibodies, combination products, and other complex biologics. • Provide guidance on BLA strategy, expedited pathways, regulatory risk assessment, CMC, nonclinical and clinical requirements, labeling, and post-approval strategy. • Lead all aspects of health authority interactions. • Support regulatory due diligence activities. • Serve as a senior strategic advisor and primary client contact. • Build long-term biotech and pharmaceutical client relationships. • Lead multidisciplinary consulting teams and mentor junior staff. • Deliver high-quality regulatory recommendations, reports, and presentations. • Support business development, proposals, and client pitches. • Represent the organization at conferences and industry events. • Develop thought leadership materials and support company growth.

🎯 Requirements

• Degree in a life sciences discipline • Significant industry experience • Deep expertise in US FDA regulatory strategy for biologics. • Multiple successful BLA experiences with direct FDA interactions. • Significant experience with complex modalities, such as combination products and cell and gene therapies • Strong consulting, leadership, communication, and presentation skills.