US Regulatory Lead
O2 Technologies
Key Responsibilities & Skills Process Mapping & Authoring for Submissions External Innovation Assessment (Regulatory) Oncology & Neurology Therapeutic Knowledge Regulatory Strategy Development US Regulatory Compliance US FDA Regulatory Requirements IND / NDA / BLA Submission Management Regulatory Research & Intelligence Cross-Functional Team Representation Process Mapping & Authoring for Submissions External Innovation Assessment (Regulatory) Oncology & Neurology Therapeutic Knowledge Project Deliverable Coordination Regulatory Strategy Development US Regulatory Compliance Technical Skills eCTD / FDA Submission Portal Regulatory Intelligence Tools Document Management Systems Education Bachelor's Degree (BS/BA) in Pharmacy, Pharmacology, Biology, Chemistry, Biomedical Sciences. Preferred: Master's Degree (MS), PhD, PharmD, MBA. Industry Experience Pharmaceuticals Oncology Neurology Clinical Development Regulatory Affairs
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