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Ash Patel Email & Phone Number

Global Head, Regulatory CMC (Biologics) and GRL at Viatris
Location: United Kingdom, United Kingdom, United Kingdom 10 work roles 1 school
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Current company
Role
Global Head, Regulatory CMC (Biologics) and GRL
Location
United Kingdom, United Kingdom, United Kingdom
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Who is Ash Patel? Overview

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Ash Patel is listed as Global Head, Regulatory CMC (Biologics) and GRL at Viatris, a company with 17469 employees, based in United Kingdom, United Kingdom, United Kingdom. AeroLeads shows a matched LinkedIn profile for Ash Patel.

Ash Patel previously worked as Global Head, Regulatory CMC (Biologics) & GRL at Viatris and Senior Director & GRL, Regulatory CMC (Biologics) at Viatris. Ash Patel holds Doctor Of Philosophy (Ph.D.) & B.Sc., Biochemistry from University Of Liverpool.

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Viatris

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Profile bio

About Ash Patel

Senior pharmaceutical professional with global expertise in regulatory affairs and drug development with experience in R&D, CMC, project management, strategy and operations, manufacturing, quality and business development. Adept at due diligence, in-licensing, and strategic partnerships within the life science industry.Proven leadership skilled focused on synergy between strategy and operation, enabling delivery of high-quality products whilst navigating ambiguity to deliver innovative problem-solving solutions. Committed to leading cross-functional and multicultural teams on therapeutic antibodies, recombinant proteins, vaccines, exosomes, and cell and gene therapeutics with strategic foresight and an innovative mindset. A passion for delivering patient-centric regulatory strategies for oncology, autoimmune, cardiovascular, metabolic, neurodegenerative and rare diseases to meet the dynamic demands of the life sciences field.Skilled in regulatory agency interactions, conducting training sessions on product development and regulatory guidance. Demonstrated ability to manage complex strategic projects, driving growth and profitability in a fast-paced pharmaceutical environment with a diverse portfolio of molecules.

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Ash Patel's current company

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Viatris
Viatris
Global Head, Regulatory CMC (Biologics) and GRL
United Kingdom
Website
Employees
17469
AeroLeads page
10 roles · 37 years

Ash Patel work experience

A career timeline built from the work history available for this profile.

Global Head, Regulatory Cmc (Biologics) And Grl

United Kingdom

Global Head, Regulatory Cmc (Biologics) & Grl

Current

Lead a Global Regulatory team providing technical, strategic and operational leadership across a rapidly growing biosimilars portfolio, work through cross-functional teams & external partners, suppliers & contract manufacturers to ensure timely regulatory submissions.

Nov 2020 - Present

Senior Director & Grl, Regulatory Cmc (Biologics)

Mar 2019 - Nov 2020

Head Of Cmc, Manufacturing And Supply Chain

Accountable for technical, strategic and operational leadership for process development, Manufacturing, Device development, Supply chain Logistics and outsourcing CMO / CRO activities

Nov 2017 - Feb 2019

Head Of Product Development, Manufacturing & Regulatory Affairs

Oxford, England, United Kingdom

Part of the leadership team to harness and engineer natural trafficking capabilities of exosome from stem cells to develop an entirely novel class of biotherapeutics for orphan diseases.

Aug 2017 - Nov 2017

Senior Director, Consultant (Biopharmaceutical & Biosimilars)

Biopharmaceutical technical expertise for an orphan indication on scientific, technical, regulatory, external manufacturing, technology transfer and outsourcing CRO activities and life cycle management.Early phase biosimilar development, manufacturing, quality and regulatory expertise on a portfolio of therapeutic antibodies

Nov 2015 - Aug 2017

Director Of Regulatory Affairs (Biologics)

Era Consulting

London, United Kingdom

Director of Regulatory Affairs (Biologics), providing consultancy related to quality, nonclinical, clinical aspects of Biopharmaceutical development from development strategies to regulatory requirements in Europe / US. Experienced in all phases of drug development and life cycle management for therapeutic proteins (Mabs, Insulins, Interferons.

Apr 2014 - Oct 2015

Director, Medicines & Process Development Leader, Biopharmaceutical R&D

Stevenage, United Kingdom

  • Lead cross-functional matrix teams from pre-clinical through to late phase/post approval activities associated with management of the process, the product, CMC regulatory submission and the supply chain. Accountable.
  • Manufacture / Supply chain for pre-clinical, clinical & commercial product
  • Partnering joint development teams with external clients
  • Process development / validation (from cell bank to finished product)
  • Quality requirements for licensure
  • Project management / Budget management
Oct 2009 - Apr 2014

Cmc Leader / Medicines & Process Development Manager

Gsk

Accountable for all CMC aspects on Early Phase assets (pre-clinical stage through to Proof of Concept), including manufacturing, Quality, regulatory files, project management, budget management, mentoring & coaching,etc.

2004 - 2009 ~5 yrs

Transition: Scientist To Manager (With Increasing Responsibility)

Gsk

Research & Development of BioPharmaceuticals (with increasing seniority and responsibilities). Experienced in managing an International team of Bioassay specialist. Also accountable for lead/ managing a team of 15 scientists.

1989 - 2004 ~15 yrs
1 education record

Ash Patel education

FAQ

Frequently asked questions about Ash Patel

Quick answers generated from the profile data available on this page.

What company does Ash Patel work for?

Ash Patel works for Viatris.

What is Ash Patel's role at Viatris?

Ash Patel is listed as Global Head, Regulatory CMC (Biologics) and GRL at Viatris.

Where is Ash Patel based?

Ash Patel is based in United Kingdom, United Kingdom, United Kingdom while working with Viatris.

What companies has Ash Patel worked for?

Ash Patel has worked for Viatris, Akari Therapeutics Plc, Evox Therapeutics Ltd, Ipsen & Polpharma, and Era Consulting.

How can I contact Ash Patel?

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What schools did Ash Patel attend?

Ash Patel holds Doctor Of Philosophy (Ph.D.) & B.Sc., Biochemistry from University Of Liverpool.

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