... responsibility for global regulatory strategy within a development team (DT). Serve as team lead or co-lead of marketing application submission teams for indications that are at the regulatory filing stage ...

... using real-world data to facilitate and support development and regulatory interactions of ... . Additionally, the role involves representing the organization in interactions with regulatory agencies ...

... , specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices ... Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry ...