The Director, Global Regulatory Affairs provides scientific and related regulatory expertise regarding preclinical and clinical research and CMC, as well as product development support, for either internal customers or external clients, for investigational medicinal products, including chemical entities, biologicals, biotech products, advanced therapies and medical devices. Participates in project teams or may provide service as an independent expert. Provides regulatory strategy, due diligence, regulatory scientific review of regulatory submissions - NDA/BLA, IND, MAA, CTA, CTD, NDS submissions etc. Leads and coordinates Agency/authority interactions for multiple projects. Provides functional management to the regulatory affairs department staff.