Stephane M.S.’s Email & Phone

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Stephane M.S.

Director of Regulatory Affairs CMC @ Merck

Stephane M.S. Contact Details

Location:
Kenilworth, New Jersey, United States
Work:
Director of Regulatory Affairs CMC @ Merck
Director, BioPharm CMC Regulatory Affairs @ GSK
Associate Director, BioPharm CMC Regulatory Affairs @ GSK
Education:
B.S., Biology @ Université Joseph Fourier (Grenoble I)
About:

Technical/CMC Regulatory professional with: - Development (pre-IND, phase I/II/III, including CTA/IMPD), BLA & Post-Market experience with Biologics and Combination Products (Antibody Drug Conjugates, Drug/Device). - Multiple interactions with FDA (Face to face Type B/C meetings in Washington DC, teleconference Type C meetings, informal teleconference calls, written communications...) - Strong scientific knowledge of the biologic drug substance & 

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