US Regulatory Strategy Lead
Core
Develops US regulatory strategies for assigned development and marketed products, focusing on risk assessments, mitigation, and expedited pathways to accelerate patient access.
Role type
Senior US Regulatory Strategy Lead
Builds
US regulatory strategies and submission packages for biopharmaceutical products
Domain
Biopharmaceuticals / Rare Diseases / US Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
US regulatory framework knowledge, FDA meeting leadership, major application delivery (NDA/BLA), risk assessment, regulatory pathway evaluation, submission taskforce management, consultant coordination, labeling contribution, due diligence assessment, operational excellence, industry event representation, regulatory impact monitoring
Preferred skills
Immunology late-stage development experience, advanced degree (PhD, PharmD, MD)
Technologies
FDA pathways (ODD, FTD, Accelerated Approval, Priority Review), GMPs, GLPs, GCPs
Responsibilities
Weave US strategies into global strategies, serve as point of contact for core asset and medicines development teams, prepare and lead major FDA meetings, triage FDA Information Requests, contribute to submission taskforces, manage regulatory consultants, act as key FDA contact, contribute to US product labeling, execute IND/NDA/BLA submissions, participate in due diligence, review regulatory SOPs, monitor US regulatory environment
Seniority
Senior, hands-on IC
