Associate Director/Director, Regulatory Writing and Operations
Position Summary The AD/Director, Regulatory Writing and Operations is responsible for the medical writing and operational aspects of all submissions to U.S. and international Regulatory Agencies, managing the planning, tracking, coordinating, compiling, submitting, and archiving of submissions, and ensuring that documents and submissions are of the highest quality and delivered on-time to meet U.S. and international regulatory requirements and company objectives. Primary Responsibilities Accountable for ensuring accurate, compliant and timely medical writing deliverables and regulatory submissions Create and manage submission plans in conjunction with Regulatory Affairs strategy and CMC leads, cross-functio
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