VP, Head of Regulatory Affairs, Astellas Gene Therapies @ (July 2021 - April 2025)
Vice President @ Astellas Pharma US (April 2023 - April 2025)
Global Regulatory TA Head (ID, Inflammation and Immunology, Transplant, Pain and Neurosciences) @ Astellas Pharma (October 2015 - July 2021)
Senior Director, Global Regulatory Portfolio Leader, Worldwide Regulatory Affairs @ (January 2010 - October 2015)
Director, Global Regulatory Team Lead @ (January 2006 - January 2010)
Associate Director, Global and EU Regulatory Team Lead @ (January 2004 - January 2006)
Regulatory Project Manager (Global and EU) @ (January 2001 - January 2004)
Regulatory Executive @ (January 1999 - January 2001)
Regulatory Affairs Officer @ (January 1997 - September 1999)
Research Assistant @ The University of Liverpool, UK (June 1995 - September 1996)
David Smethurst Education
University of Liverpool
B.Sc (Hons) (Pharmacology)
1992-1996
The Lakes School, Cumbria, UK
David Smethurst Skills
Strategic Thinking
Business Strategy
Critical Thinking
Regulatory Guidelines
Problem Solving
Coaching & Mentoring
IND
Therapeutic Areas
Pharmaceutical Industry
Leadership
Regulatory Affairs
Clinical Trials
Regulatory Submissions
Neuroscience
Clinical Development
Drug Development
eCTD
Cross-functional Team Leadership
Pharmacovigilance
Biopharmaceuticals
Oncology
Infectious Diseases
Regulations
Strategy
Change Control
Lifesciences
Biotechnology
Due Diligence
Management
GCP
Regulatory Requirements
Life Sciences
Electronic Common Technical Document (eCTD)
Good Clinical Practice (GCP)
Cross Functional Team
Regulatory
Good Clinical Practice Gcp
Cross Functional Team Leadership
Electronic Common Technical Document Ectd
R&d
Electronic Common Technical Document
Good Clinical Practice
David Smethurst Summary
David Smethurst, based in New York, NY, US, is currently a Head, Regulatory Strategy Biopharma and Ophthalmology at Astellas Pharma. David Smethurst brings experience from previous roles at Astellas Pharma, Astellas Pharma US and Pfizer Global R&D. David Smethurst holds a 1992 - 1996 B.Sc (Hons) in Pharmacology @ University of Liverpool. With a robust skill set that includes Strategic Thinking, Business Strategy, Critical Thinking, Regulatory Guidelines, Problem Solving and more. David Smethurst has 2 emails and 1 mobile phone numbers on RocketReach.
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