Senior Director, Regulatory Affairs
mike.page@unitedbiosource.com
Mike Page is a Senior Director who provides regulatory services for clients at all stages of their product’s lifecycle, developing high quality regulatory strategies and ensuring effective engagement of regulatory authorities.
Mike has been involved in drug discovery and development for over 19 years, of which more than 12 years have been in a regulatory affairs role at Pfizer. Mike’s strategic leadership has resulted in positive outcomes in a number of critical regulatory authority interactions. He has provided regulatory input at all stages of product lifecycle from pre-clinical development through marketed product support and has worked in several therapeutic areas including oncology, psychiatry, urology, sexual medicine, rheumatology and cardiovascular medicine. Mike has experience of both small molecule and biologic drug development.
Mike was the Global Regulatory Lead for Pfizer’s smoking cessation project and was responsible for the US NDA which achieved first cycle approval. Previously based in the United Kingdom, Mike has obtained several clinical trial authorizations and marketing approvals in Europe, working closely with key European national regulatory authorities and with the European Medicines Agency. He also has experience with new drug approvals in Japan.
Mike received a Bachelor of Science degree in biochemistry with honors from the University of Hull (UK).