Ash Patel Email and Phone Number
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.
Viatris
View- Website:
- viatris.com/en
- Employees:
- 17469
-
Global Head, Regulatory Cmc (Biologics) And GrlViatrisUnited Kingdom
-
Global Head, Regulatory Cmc (Biologics) & GrlViatris Nov 2020 - PresentLead 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.
-
Senior Director & Grl, Regulatory Cmc (Biologics)Viatris Mar 2019 - Nov 2020
-
Head Of Cmc, Manufacturing And Supply ChainAkari Therapeutics Plc Nov 2017 - Feb 2019Accountable for technical, strategic and operational leadership for process development, Manufacturing, Device development, Supply chain Logistics and outsourcing CMO / CRO activities -
Head Of Product Development, Manufacturing & Regulatory AffairsEvox Therapeutics Ltd Aug 2017 - Nov 2017Oxford, England, United KingdomPart 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. -
Senior Director, Consultant (Biopharmaceutical & Biosimilars)Ipsen & Polpharma Nov 2015 - Aug 2017Biopharmaceutical 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 -
Director Of Regulatory Affairs (Biologics)Era Consulting Apr 2014 - Oct 2015London, United KingdomDirector 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, erythropoietin,, etc), Biosimilars, vaccines and ATMPs. Provide ERA’s expertise on due diligence activities, quality audits, gap analysis of regulatory dossiers (IND, IMPD, MAA), scientific advisory meetings and agency interactions. Also involved in business development, project / budget management.
-
Director, Medicines & Process Development Leader, Biopharmaceutical R&DGlaxosmithkline Oct 2009 - Apr 2014Stevenage, United KingdomLead 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 for activities related to the following: • 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• Lead matrix team for selection of auto-injectors -
Cmc Leader / Medicines & Process Development ManagerGsk 2004 - 2009Accountable 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.
-
Transition: Scientist To Manager (With Increasing Responsibility)Gsk 1989 - 2004Research & 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.
Ash Patel Education Details
-
Biochemistry
Frequently Asked Questions about Ash Patel
What company does Ash Patel work for?
Ash Patel works for Viatris
What is Ash Patel's role at the current company?
Ash Patel's current role is Global Head, Regulatory CMC (Biologics) and GRL.
What schools did Ash Patel attend?
Ash Patel attended University Of Liverpool.
Not the Ash Patel you were looking for?
-
Ash Patel
Director - Blakemore Recruitment - Financial Services & Wealth Management RecruitmentGreater London2clarkjames.co.uk, blakemorerecruitment.co.uk1 +447989XXXXXX
-
Ash Patel
Working With Brilliant People To Make A Difference And Having A Great Time Doing ItGreater London4bankofengland.co.uk, me.com, wellsfargo.com, barclays.com -
1hotmail.co.uk
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial