Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
Who are we?
We Are PRA.
We are 16,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
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.