Robert S.
Associate Director Regulatory Affairs, Cmc & Labelling @Cycle Pharmaceuticals
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WORK HISTORY
Associate Director Regulatory Affairs, Cmc & Labelling @Cycle Pharmaceuticals
Cambridge, GB
CMC Pre- and Post-Approval Lead- Pre-IND Authoring, Regulatory Strategy & NDA authoring of modules 1,2, & 3 - Management and Oversight of CMC and Labelling Teams- Regulatory Systems Lead- Due diligence assessment of third party dossiers and contracts- CMC Training and Development- Management of CMC budget/invoices
EDUCATION
University of Aberdeen
MSc
University of Surrey
BSc
University of Strasbourg (EEHICS)
Yr 2 of Diplome d'Ingenieur
ECPM Ecole européenne de chimie polymères et matériaux de Strasbourg
Bachelor's degree
ABOUT ROBERT S.
Regulatory Affairs Professional with 20 years experience in the Pharmaceutical Industry comprising roles in Regulatory Affairs, Compliance, IT Training and Systems Development. Specialties include :* Systems development and training; SAP, Trackwise, RIM, Documentum, VEEVA * Regulatory Conformance / Compliance * NDA CMC dossier preparation * Post Approval CMC Lifecycle management (RAC EU Accredited)* Agency interation * Process Improvement & Systems Development * Visual Basic Programming for Excel * Project Management (PRINCE2)* Line Management, Training & Development * Design of Change Control / Variation Tracking Systems * Analytical Chemistry
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