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Suki Bansal

EU Director Regulatory Affairs, Oncology @ AstraZeneca Pharmaceuticals

EU Director Regulatory Affairs, Oncology at AstraZeneca Pharmaceuticals

Ilford, United Kingdom

Ranked #1,133 out of 22,660 for EU Director Regulatory Affairs, Oncology in United States

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Suki Bansal's Email Addresses & Phone Numbers

Suki Bansal's Work Experience

AstraZeneca Pharmaceuticals

EU Director Regulatory Affairs, Oncology

October 2015 to Present

Cambridge, United Kingdom

Mitsubishi Tanabe Pharma Europe Ltd

Deputy General Manager, Regulatory Affairs Clinical

January 2013 to September 2015

London, United Kingdom

Mitsubishi Pharma Europe

Senior Manager Regulatory Affairs

September 2007 to December 2012

London, United Kingdom

Suki Bansal's Education

University of Greenwich

BSc (Hons) Pharmaceutical Sciences

1991 to 1995

Suki Bansal's Professional Skills Radar Chart

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Strong sense of self

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Suki Bansal's Estimated Salary Range

About Suki Bansal's Current Company

AstraZeneca Pharmaceuticals

Frequently Asked Questions about Suki Bansal

What company does Suki Bansal work for?

Suki Bansal works for AstraZeneca Pharmaceuticals

What is Suki Bansal's role at AstraZeneca Pharmaceuticals?

Suki Bansal is EU Director Regulatory Affairs, Oncology

What is Suki Bansal's personal email address?

Suki Bansal's personal email address is su****[email protected]

What is Suki Bansal's business email address?

Suki Bansal's business email address is s****[email protected]

What is Suki Bansal's Phone Number?

Suki Bansal's phone +44 ** **** *149

What industry does Suki Bansal work in?

Suki Bansal works in the Pharmaceuticals industry.

About Suki Bansal

📖 Summary

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

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In a nutshell

Suki Bansal's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

2 year(s), 8 month(s)

Suki Bansal's Willingness to Change Jobs



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