Suki Bansal's Email

EU Director Regulatory Affairs, Oncology @ From October 2015 to Present (3 months) Cambridge, United KingdomDeputy General Manager, Regulatory Affairs Clinical @ Regulatory strategy for development compounds (Phase I to Phase III). Oversight of clinical trial operational regulatory activites (submissions, approvals, amendments and CRO management). Regulatory lead for GCP & PV inspections. Training, coaching and mentoring staff. Recruitment. From January 2013 to September 2015 (2 years 9 months) London, United KingdomSenior Manager Regulatory Affairs @ European lead for two Phase II development compounds. European lead of a Centralised Marketing Authorisation Application from submission to approval. CHMP Scientific Advice. Paediatric Investigational Plan - Scientific Advice, preparation, submission and approval of PIP. Marketed product life cycle management. Line management. From September 2007 to December 2012 (5 years 4 months) London, United KingdomRegulatory Affairs Manager @ Project Lead - Managment of a centralised MAA for an orphan medicinical product. Activities undertaken included trade name application, ATC/DDD code application, pre-submission meeting document preparation, preparation of CTA documentation for submission to 11 MS's. Management of UK & Ireland regulatory activities. Supporting UK & Ireland commercial teams - Responsible for promotional material review and sign off in accordance with ABPI code of practice and brand team support. From February 2007 to September 2007 (8 months) Regulatory Affairs Manager @ Line Management of 5 direct reports. Responsibilities included work allocation, addressing personnel issues, performance management, recruitment, budgets, coaching and mentoring. Accountability and responsibility for several projects. Development of an artwork change control procedure; preparation and submission of an orphan drug application; updating NCE file into CTD format; MRP's (1st, 2nd, 3rd round waves) for two NCE's; product life cycle management of marketed products. Supporting UK commercial activities. Food Supplement labelling strategy and evaluation. Regulatory intelligence. From April 2002 to December 2006 (4 years 9 months) Regulatory Affairs Executive @ Project Management of NCE - Activities included preparation of project plan, gap analysis and identification of critical milestones, preparation of Modules 1 to 3 in CTD format, publishing and dispatch of completed dossier to the Agency. Preparation of Part II for NCEand associated CMC formats for Module 1. Product Life Cycle Managment - National and MRP Variations. Preparation of DMF responses for a centralised application. From September 2000 to April 2002 (1 year 8 months) Senior Registration Officer @ Preparation and submission of National and Mutual Recognition Abridged and Simple Abridged Marketing Authorisation Applications and responses. Preparation and submission of Clinical Trial Applications. Product life cycle management - Type I and II variations. From May 1997 to September 2000 (3 years 5 months)

BSc (Hons), Pharmaceutical Sciences @ University of Greenwich From 1991 to 1995 Suki Bansal is skilled in: CMC, Regulatory Affairs, Regulatory Submissions, CTD, Regulatory Requirements, Pharmaceutical Industry, eCTD, Regulatory Intelligence, IND, Pharmacovigilance, Clinical Development, Clinical Trials, GCP, Drug Development, FDA, CRO, SOP