Robert Searson
Associate Director Regulatory Affairs, Cmc @Cycle Pharmaceuticals
Signup · Get unlimited contacts
WORK HISTORY
Associate Director Regulatory Affairs, Cmc @Cycle Pharmaceuticals
Cambridge, GB
Pre-IND Authoring, Regulatory Strategy & NDA authoring of modules 1,2, & 3 - Post Approval CMC specialist for EU/UK & CH (Type II, IB), CA, MENA and US markets (CBE-0/30, PAS)- Authoring of Orphan Drug Application - EU - IRIS manager - Due diligence assessment of third party dossiers and contracts- Management of CMC budget/invoices - Veeva Vault Systems Administrator- Assessment of process development protocols/reports. Validation protocols/reports/batch records - Resolution and troubleshooting of manufacturing and analytical chemistry issues- Line Management / Recruitment- Designed, coded and implemented software for a companywide Change Control Database (HA inspected)- SOPs, User Guides and UAT authoring.
EDUCATION
University of Aberdeen
MSc, Analytical Chemistry, Spanish
University of Strasbourg (EEHICS)
Yr 2 of Diplome d'Ingenieur, Chemistry
University of Surrey
BSc, Chemistry, French
ABOUT ROBERT SEARSON
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 * Post Approval CMC Lifecycle management (RAC EU Accredited)* Process Improvement & Systems Development * Visual Basic Programming for Excel * Project Management (PRINCE2)* Line Management * Design of Change Control / Variation Tracking Systems * IT Training * Analytical Chemistry
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.