Sjaak Bot

Janssen

Sjaak was a member of the GRA Regional Regulatory Affairs Management Team as well as the Janssen EMEA Leadership Team. He was responsible for building and leading an integrated EMEA regulatory affairs organization covering all therapeutic areas as well as all operating company regulatory teams in the Janssen EMEA organization. Sjaak served as a Board Member for Janssen Biologics BV (JBV) and Chairman of the JBV “Marketing Authorization Holder and Sponsor’ Committee. Since 2009, he served as Vice President EMEA Regulatory Affair for the Immunology Therapeutic Area and lead activities in all regulatory aspects and early and late development products in the immunology profile. In addition, he led the operating company regulatory organizations in the EEA region, where he successfully implemented a platform for knowledge-sharing, harmonization, improved compliance and better efficiency. Sjaak joined Johnson and Johnson in 2002, and prior to that, he held leadership positions in regulatory affairs, quality and reimbursement in Yamanouchi Europe and Sanofi, the Netherlands. Sjaak has a Pharmacist Degree from the University of Leiden, the Netherlands.
profile of Sjaak Bot

Sjaak Bot is contributing to the following courses

Market Approval Online

Market Approval is mandatory at various milestones in the development of your novel biomedical intervention and need to be passed to move your product to the market and beyond.

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