A versatile senior leader with over 15 years of experience across Quality Control, Regulatory Affairs, Analytical Development, and Manufacturing leveraging emerging technologies within the pharmaceutical, biotherapeutics and cell therapy sectors. Expert in managing GMP compliance, technology transfers, and regulatory support for IND and IMPD filings. Proven ability to manage cross-functional teams using agile project management to align technology transfers and regulatory strategies with corporate objectives, driving innovation in product development. Currently leading the Pharma function at Optimal, has experience driving successful MHRA inspections, pre-clinical to late phase experience and establishing QC labs with cutting-edge technologies. Proficient in a range of analytical techniques in microbiology, molecular biology, physical-chemical techniques, bio and functional assays, regulatory support (IND, IMPD), and GMP compliance. Adept at matrix management, technical development, and fostering collaboration across diverse teams. Currently pursuing an MSc in Regulatory Affairs – Medicines (TOPRA) to expand my expertise in global regulatory landscapes FDA and EMA guidelines.
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