Experienced Regulatory Scientist (>15 years) with a primary interest in advanced therapies (ATMP, cell, gene and tissue products) and other regenerative medicine products including protein therapeutics. Providing ICH-level quality/CMC and preclinical ‘regulatory science’ support and EU regulatory procedure/law support based on a deep knowledge gained from working in both biotech and regulatory agency. Deep understanding of EU clinical trials (IMPD), EMA licensing (MAA) and post-licensing (variations) requirements gained from time as an assessor (MHRA/EMA) and supporting a wide variety of clients over many years.
Principal scientific discipline is transplantation immunology (PhD) combined with experience in target validation, protein chemistry, metrology, tissue engineering, renal medicine, molecular biology, and stem cell research. Proven track record for delivering results on time (project, regulatory submission or assessment) and within budget. Proactive customer-focused service resulting in high rates of return business and customer satisfaction. Enthusiastic and self-motivated, thriving on challenge, with a high level of transferable, technical and analytical skills. Excellent communicator with considerable experience in giving presentations and workshops and training courses (biotech and ATMP) both nationally and internationally and numerous peer reviewed publications.