Job Details

A company is looking for an Early Development Global Regulatory Lead.Key ResponsibilitiesAct as a key member of the Early Development regulatory team and contribute to developing regulatory strategiesCo-create and implement innovative global regulatory strategies to expedite development milestonesOversee regulatory affairs vendors and ensure high-quality interactions with regulatorsRequired QualificationsMinimum 15 years of regulatory affairs experience in biopharmaceutical organizations, with 5-7 years in global leadership rolesPhD or PharmD preferredThorough understanding of the drug development process and expertise in orphan drugsExperience interacting with regulatory authorities, especially the FDA and EMAProven ability to build, motivate, and develop a team