Chris has two responsibilities within Voisin Consulting Life Sciences (VCLS). As Senior Director, he manages projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics; and as Head, Medical Writing, he provides leadership for this function.
Chris has almost 30 years of experience in the pharmaceutical industry. He started his career in quality assurance, working in both GLP and GCP arenas, before transitioning to pharmaceutical regulatory affairs 20 years ago.
Prior to joining VCLS, Chris headed up the regulatory and medical writing groups at Ergomed, where he spent 13 years. In addition to line-management responsibilities, he was responsible for the review and sign-off of deliverables to ensure they met both regulatory and client requirements.
He has extensive experience and insight in supporting pre-market activities (review of data, compilation and filing of clinical trial applications, drug labelling, IMP release and distribution) from a long collaboration with several contract research organizations. He has also gained extensive medical writing experience, from his early days auditing preclinical and clinical study reports, through the drafting and editing of summaries and “expert” reports to support marketing authorization applications, to the compilation of EU grant applications and more recently as a main contributory author in “Orphan Drugs, understanding the rare disease market and its dynamics”, Woodhead Publishing.
Chris has been closely involved in the clinical development of a wide range of products including those in oncology, immunology, asthma and neurology, through phases I to IV of clinical development.
Chris has a solid knowledge of EU regulatory requirements, and was responsible for the filing of an MAA under the centralized procedure. He was then responsible for EU license maintenance and for subsequent filing in a number of “Rest of the World” territories (approximately 20 countries) until the transfer of the license holder.
Chris has considerable experience of working successfully in a multi-lingual and multi-cultural environment and has developed excellent communication skills to liaise confidently with clients, colleagues and regulators.
Chris earned his B.Sc. in zoology from Sheffield University, and an M.S.c. in toxicology from the University of Surrey, UK.