Introduction to Regulatory Affairs

Monday June 22nd

About Janssen

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

In the Netherlands we are the #4 largest R&D investor across all sectors and the #1 in pharma. We have major R&D facilities in Leiden focusing on vaccine development for e.g. COVID-19, HIV, RSV, ExPEC and Ebola, and monoclonal antibodies for use in neuroscience, immunology and cancer treatment, as well as support functions such as regulatory affairs and clinical development. Just across the Belgian border in Beerse, the Janssen Pharmaceutica Campus is Johnson & Johnson’s largest R&D site globally.

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About Sjaak Bot

Sjaak Bot

Since March 2020 Sjaak is Senior Advisor Global Regulatory Affairs for Janssen. In that role he leads several global business-improvement initiatives for Janssen and Johnson & Johnson Regulatory Affairs. At a local level, Sjaak serves as a Board Member for Janssen Biologics BV in Leiden. He is also member of the Strategic Management Board of the Janssen Campus the Netherlands. Sjaak joined Johnson & Johnson in 2002 as Head of Regulatory Affairs Europe for Centocor, which transitioned into Janssen GRA-EMEA Immunology in 2008. In 2013, he was appointed to his previous role as Head of Janssen EMEA Regulatory Affairs, covering all therapeutic areas, as well as the EMEA OpCo Regulatory teams. Under his leadership, EMEA Regulatory Affairs successfully obtained approvals in EMEA for new products and major line extensions including major brands in oncology, immunology and neuroscience. Sjaak developed a strong EMEA regulatory team, and he initiated several key strategic initiatives within Janssen GRA.

Before joining Johnson & Johnson in 2002, Sjaak 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.

Jumpstart your career

Join BioBusiness Summer School to jumpstart your career in Life Sciences by gaining knowledge of business aspects such as product development, IPR, finance and business models. The next edition of the summer school will take place from 28 June to 2 July 2021!

Why participate

The BioBusiness Summer School is a programme tailored to bridge the gap. By immersing yourself in the business aspects of Life Sciences during this programme, you will learn the basic knowledge of BioBusiness, gain insight in the world of Life Sciences companies, meet leading business leaders and increase your international network.

Employers meet talent

Is your organisation interested in early-career talents in Life Sciences? BioBusiness Summer School can get you in touch with business oriented PhDs, postdocs or Master students. More info can be found here.