Profile Details

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Hire Ash P.

United Kingdom

USD 120 /hr

Experienced CMC Regulatory Affairs Leader specialising in biologics and ATMPs (15+ years).

Profile Summary

Highly motivated and scientifically driven regulatory professional with over 15 years of experience in the biopharmaceutical industry, spanning Regulatory Affairs, Quality Control, Quality Assurance, and R&D Analytical Development. Proven track record of successfully leading global regulatory projects, managing cross-functional scientific teams, developing and executing regulatory strategies, and engaging effectively with health authorities worldwide. Comprehensive knowledge of the entire drug development process and product lifecycle, with hands-on experience authoring regulatory submissions including EU CTAs, US INDs, and marketing authorisations (BLAs and MAAs). Broad therapeutic expertise across Respiratory, Oncology, Pain, Infectious Diseases, Haematology, and Gastroenterology.

Subject Matter Expertise

• ★ Regulatory Affairs
• ★ Regulatory Writing
• ★ CMC Documentation
• ☆ Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ Product Compliance
• ☆ NDA/BLA Applications
• ☆ Investigational New Drug (IND) Application Writing

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Copywriting, Newswriting

Research Fact Checking, Gap Analysis

Consulting Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Stability/Shelf Life Testing, Product Validation, Manufacturing

Work Experience

Director, Regulatory Affairs CMC

Kyowa Kirin International

September 2024 - Present

Global Head of CMC Regulatory Affairs

Achilles Therapeutics

April 2021 - September 2024

Regulatory Manager

Glaxo SmithKline

April 2019 - April 2021

Regulatory Consultant

DLRC Regulatory Consultancy

December 2016 - March 2019

Technical lead Biologics

Glaxo SmithKline

December 2013 - March 2016

Senior Development Scientist

Lonza

October 2009 - December 2013

Education

Masters of Science

University of Nottinham

September 2008 - September 2009

BSc Hons Biomedical Sciences

University of Central Lancashire

September 2004 - July 2007

Certifications

• Certification details not provided.