Director / Senior Director, Regulatory Strategy

Director / Senior Director, Regulatory Strategy Clinical-stage biotech | San Francisco Bay Area | HybridWe're partnering with an innovative clinical-stage biotech that is advancing novel biologic therapies in areas of high unmet need. As the pipeline progresses through the clinic, the company is looking for a strategic, hands-on regulatory leader to shape and drive global development strategy. The title will depend on experience.The opportunityLead global regulatory strategy for one or more clinical programs, from early development through later-stage planningAct as a key regulatory point of contact with FDA and other health authoritiesLead the strategy and preparation for health authority interactions, INDs, CTAs and key submissionsPartner closely with clinical, CMC, nonclinical and program leadership as a core member of development teamsShape regulatory pathways, including expedited programs, as assets progressThe profileAdvanced scientific degree preferred, with progressive regulatory strategy experience in biotech or pharmaDirect experience leading health authority interactionsBackground in biologics and immunology or oncology strongly preferredThrives in a lean, collaborative environment and is comfortable balancing strategy with executionClear communicator who can influence cross-functional and executive stakeholdersWhy considerHigh-visibility role with real influence on pipeline directionInnovative science with meaningful patient impactCollaborative, scientifically driven cultureFor a confidential conversation, reach out to Sydney Hewitt at EPM Scientific - sydney.hewitt@epmscientific.com