Stef C. Schutte, Pharm.D., M.Sc.

Stef Schutte is a seasoned global Regulatory Affairs specialist, with more than 35 years in the pharmaceutical industry. 

Since 2025, Stef is General Manager in Europe and Regulatory expert for Celegence, a tech -enabled regulatory service provider. Prior to his current role, he was with Astellas as an executive Vice President for over 10 years, leading the global Regulatory Affairs division end to end. At that time, Stef was also a Board member and statutory director for Astellas Pharma Europe BV and its parent company, Astellas BV. Stef also served as a Board member for the US based company Accumulus Synergy, developing cloud-based regulatory collaboration software.

Stef achieved his M.Sc. in Pharmaceutical Sciences at the State University of Leiden and worked at ICI Pharma in Germany before earning his Pharm. D. at the State University of Utrecht in 1988. He joined Katwijk Farma for a short time before completing his military service as Head of Pharmaceutical Policy at the Ministry of Defense in The Hague. Stef spent almost a decade at Solvay Pharmaceuticals working in the areas of CNS and infectious diseases in addition to further responsibilities for the company’s veterinary portfolio. He joined Organon in 1998 and went through the evolution of this company, first to Schering-Plough and then MSD. With initial responsibility for the Medical Biological section of Organon’s regulatory affairs department, Stef covered the reproductive health portfolio from pre-clinical to Phase III and later expanded his remit to include CNS and the global regulatory strategy group at Schering-Plough in the US. In 2011, Stef was responsible for biologics and vaccines at MSD, following which he led the MSD RA organization for EMEA, based out of Brussels.

Stef has been responsible for the filing of INDs, CTAs, NDAs, BLAs and MAAs and has achieved successful approvals for over 25 distinct new medicines worldwide. These have included small molecules, biologics and medical devices across diverse therapy areas encompassing Oncology, Neuroscience, Neuromuscular disorders, Reproductive Medicine, Ophthalmology, Cardiovascular Diseases, Infectious Diseases, Urology, Diabetes, Nephrology and Vaccines.