Global reference partner to expedite access of HealthTech products to regulated markets.
Senior Director – US Regulatory Strategy
Location
California + 1 moreAll locations: California | Massachusetts
Posted
11 days ago
Salary
0
Seniority
Senior
Job Description
Senior Director – US Regulatory Strategy
Voisin Consulting Life Sciences (VCLS)
• 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.
Job 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.
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