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.