Accountable for all clinical phase I-IV studies including protocol and CRF writing, CRO selection, study sites selection, tight control on CRO through all study stages, statistical analysis plan writing, report writing. Accountable for the regulation processes for all pharmaceutical products under development including regulatory consultations with regulatory agencies, KOLs, experts and NDA & MAA submissions. Ensuring that all necessary applications are filed and handling all regulatory interactions by managing regulatory relationships with a broad spectrum of regulatory agencies, including FDA, EMA and regulatory agencies in Rest of the World (RoW) countries.Achievements:Leading the clinical development and the regulatory approval of an ethical drug by the EMA (European Medicines Agency).