Senior Director – US Regulatory Strategy

🕒 June 30

🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Voisin Consulting Life Sciences (VCLS)

WebsiteLinkedInAll Job Openings

201 - 500 employees

💼 Consulting

📦 Logistics

🧬 Biotechnology

Consulting • Logistics • Biotechnology

Voisin Consulting Life Sciences (VCLS) is a global reference partner that expedites access to HealthTech products in regulated markets. With a focus on regulatory science, VCLS supports Biotechnology, Pharmaceutical, and Medtech manufacturers throughout the product development lifecycle, from discovery to commercialization. The firm offers expertise in areas such as orphan drugs, biologics, medical devices, clinical trial management, safety and vigilance, market access, and regulatory strategy. Operating in seven locations across three continents, VCLS serves a wide range of healthtech developers and investors to optimize product development and ensure successful market entry.

📋 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.