Vicky Abbott

Vicky Abbott Email and Phone Number

Global Program Regulatory Director - Immunology @ Novartis
London, GB
Vicky Abbott's Location
Gerrards Cross, England, United Kingdom, United Kingdom
Vicky Abbott's Contact Details

Vicky Abbott work email

Vicky Abbott personal email

n/a
About Vicky Abbott

I am a highly experienced regulatory professional with over 25 years experience in the pharmaceutical industry. My background includes extensive experience in developing and implementing global regulatory strategies in the development and lifecycle management of new medicinal products and also in product licence maintenance activities for the more established products.I have worked in a number of therapeutic areas including metabolism, cardiovascular, gastroenterology, oncology, neuroscience and HIV. I have extensive knowledge and experience in the European regulatory environment as well as global regulatory activities.I have experience in managing and leading teams in Europe and the US and in working collaboratively with colleagues in other countries including Japan.

Vicky Abbott's Current Company Details
Novartis

Novartis

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Global Program Regulatory Director - Immunology
London, GB
Website:
novartis.com
Employees:
79781
Vicky Abbott Work Experience Details
  • Novartis
    Global Program Regulatory Director - Immunology
    Novartis
    London, Gb
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  • Sapientia Regulatory Services Ltd
    Director
    Sapientia Regulatory Services Ltd May 2015 - Present
    Gerrards Cross
    In May 2015 I established my own regulatory consultancy company and I am currently working as an independent regulatory consultant providing regulatory services to clients.
  • Takeda Pharmaceuticals
    Executive Director / Global Regulatory Therapeutic Area Head - General Medicine
    Takeda Pharmaceuticals Jun 2012 - Nov 2014
    London, United Kingdom
    In this role I was responsible for global regulatory strategies for all projects in the General Medicine therapeutic area mainly gastroenterology and renal projects. I managed a team of regulatory professionals in Europe and the US and I represented Global Regulatory Affairs on the General Medicine Therapy Area Unit.
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  • Takeda Pharmaceuticals
    Director, Regulatory Affairs
    Takeda Pharmaceuticals Jul 2010 - May 2012
    London, United Kingdom
    In this role I provided strategic European regulatory advice in the development of new diabetes and obesity projects in all phases of development, including MAA submissions and interactions with European regulatory authorities. Between July 2011 and March 2012 I was appointed to lead the European regulatory team (approximately 20 staff) on an interim basis.
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  • Takeda Pharmaceuticals Europe Ltd
    Associate Director (Previously Manager), Regulatory Affairs
    Takeda Pharmaceuticals Europe Ltd Jun 2007 - Jun 2010
    London, United Kingdom
    In these roles I provided European and global strategic regulatory support to development projects in several therapeutic areas. I was the global regulatory lead for a new sepsis product.
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  • Kendle International
    Regulatory Group Manager
    Kendle International Jun 2005 - Jun 2007
    Cambridge, United Kingdom
    In this position I gained valuable experience in working as a consultant providing regulatory services to meet time, cost and quality requirements. I was promoted to become responsible for a team of regulatory consultants.
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  • Glaxosmithkline
    Regulatory Affairs Manager
    Glaxosmithkline Jan 2002 - May 2005
    Harlow, United Kingdom
    In this role I provided strategic European regulatory advice to global project teams for projects in all phases of development in the neurosciences and gastrointestinal therapeutic areas.
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  • Gsk
    Principal Regulatory Executive, Cmc New Submissions
    Gsk Mar 1997 - Dec 2001
    Dartford And Ware, United Kingdom
    In this role I led chemical/formulation development teams to prepare CMC documentation to support the global registration of a new anti malarial product. I attended a Pre-NDA meeting with FDA and answered questions on CMC regulatory issues. I also successfully managed global CMC regulatory activities in the development of a new HIV product from phases 1 to 3.
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Vicky Abbott Skills

Regulatory Affairs Regulatory Submissions Pharmaceutical Industry Clinical Development Biopharmaceuticals Regulatory Requirements Drug Development Ectd Clinical Trials Therapeutic Areas Pharmacovigilance Fda Cmc Gcp Biotechnology Regulatory Filings Ind Gmp Oncology Cro Pharmacokinetics Pharmaceutical Research Technology Transfer Validation Sop Pharmaceutics Diabetes Maa Medical Writing Drug Discovery Pharmacology Lifesciences Generic Programming Biologics Infectious Diseases Clinical Operations Gxp Drug Safety Clinical Pharmacology 21 Cfr Part 11 Market Access Ctms Glp Clinical Research Capa Change Control Clinical Study Design Nda Protocol Regulatory Documentation

Vicky Abbott Education Details

Frequently Asked Questions about Vicky Abbott

What company does Vicky Abbott work for?

Vicky Abbott works for Novartis

What is Vicky Abbott's role at the current company?

Vicky Abbott's current role is Global Program Regulatory Director - Immunology.

What is Vicky Abbott's email address?

Vicky Abbott's email address is v.****@****grd.com

What schools did Vicky Abbott attend?

Vicky Abbott attended University Of York, University Of Wales, Cardiff.

What skills is Vicky Abbott known for?

Vicky Abbott has skills like Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Clinical Development, Biopharmaceuticals, Regulatory Requirements, Drug Development, Ectd, Clinical Trials, Therapeutic Areas, Pharmacovigilance, Fda.

Who are Vicky Abbott's colleagues?

Vicky Abbott's colleagues are John Q, Patricia Fernandes, Pamela Mukherjee, Andy Taggart, Dang Nguyen, Mitja Andlovec, Beshoy Tharwat.

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