COMPANY & EXPERIENCE

A broad scientific and regulatory experience to meet Companies needs

He has a demonstrated global CMC and non-clinical regulatory expertise in Biologics development, approval and life-cycle maintenance with deep expertise in vaccines, therapeutic recombinant proteins, antibodies, cell bank and viral vectors together with a good knowledge in mRNA-based, cell & gene therapy and medical devices combined products. Familiar with worldwide regulatory constraints and evolving environment, including knowledge of relevant global regulations and guidelines and interaction with Authorities.

With an empowering and inclusive approach, Dr. Wilkin has led diverse and remotely located regulatory teams (up to 120 people). He is experienced at building new and leading high performing teams, including managing departmental budget and human resource. Comfortable working in a changing environment, dealing with unfamiliar situations.

Dr. Wilkin hold a PhD in Biochemistry and a master in Biochemistry (Industry Orientation) from the University of Liège, Belgium. His CV and key achievements can be found here.

BioNReg CMC Consulting is an independent free-lance consulting Company started in 2023 and owned by Jean-Marc Wilkin, PhD.

Dr. Wilkin is a highly accomplished and dedicated senior regulatory professional with more than 23 years of experience in research and development of biotechnical products at GSK vaccine division, supported by 10 years hands-on scientific knowledge acquired as a Researcher in several Public Institutions in Protein Engineering.