Mark Mannebach, PhD
VP of Regulatory Affairs
Mark Mannebach, Ph.D., R.Ph., has over thirty years of experience in the Pharmaceutical Industry, with the majority of these years in Regulatory Affairs, with additional expertise in Quality Assurance, Program Management, and Pharmaceutical Sciences. Mark has been a regulatory consultant for the last five years for several start-up biotech companies. Before being a regulatory consultant, he was the VP of Global Regulatory Affairs at Mallinckrodt Pharmaceuticals and Santen Pharmaceutical. Earlier in his career, Mark held roles of increasing responsibility at Sanofi, Pharmacia, Baxter, and Pfizer.
Mark has broad experience in developing branded & specialty pharmaceuticals and biologics in many therapeutic areas, including oncology, ophthalmology, pain management, CNS, metabolic disorders, cardiovascular diseases, and rare diseases. Mark has experience interacting and meeting with many health authorities, including FDA & Health Canada in North America, EMA, AEMPS, BfArM, MHRA, MPA & ANSM in the EU, PMDA & CFDA (NMPA) in Asia, and ENVISA (Brazil) and TGA (Australia).