- Over 15 years of experience working in scientific regulatory environments, including positions at the bench, departmental management, and providing scientific consultancy.
- Over 10 years of experience contributing to regulatory submissions and supporting regulatory audits across the pharmaceutical and next generation nicotine product industries, working with multiple Regulatory Authorities worldwide.
- Proven record in leading teams to achieve development, validation, and continual improvement of methods to support market release and stability monitoring of pharmaceutical products.
- A quality-focused mindset with a commitment to establishing long-term Client relationships through honesty and openness.
Leon Birch is a Principal Scientist within the Scientific Affairs team at Broughton. Drawing on his experience over more than 15 years of working with worldwide Regulatory Authorities, Leon is committed to delivering the highest quality of work and providing the best scientific guidance.
Prior to joining Broughton, Leon was the QC Section Manager for the Chromatography Department at Covance Laboratories, a global Contract Research Organization. Responsible for a team of 25 QC Scientists and Laboratory Analysts, Leon was accountable for the data integrity, quality, timelines, productivity, and regulatory standards within the department. Working mainly on Transfer, Validation, Stability and Market Release studies, Leon became intimately familiar with ICH, EudraLex, MHRA, and FDA requirements and guidelines to consistently deliver successfully, on time, and within budget for Clients adhering to European, United States, Japanese, Mexican and Kazakhstani Regulatory Bodies.
Leon joined Broughton as Head of Science, leading the Scientific Development team responsible for delivering validated methods for the analysis of the 33 key HPHCs required for Premarket Tobacco Product Application (PMTA) submissions. Now a member of the Scientific Affairs team, Leon is applying his experience to the study design and compilation of dossiers in support of regulatory submissions, having worked on PMTA and Marketing Authorisation Applications (MAA).