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Senior
Regulatory Associate/Regulatory Manager . |
Biotech company seeking someone that can coordinate and prepare regulatory submissions, conduct regulatory submission reviews, conduct regulatory intelligence activities to support projects, review clinical site initiation information and approve clinical shipments, coordinate and prepare CMC documentation, review and determine disposition of controlled materials received, and conduct compliance audits. Requires 2-4 years experience working in regulatory affairs in the pharmaceutical/biotechnology industry, attention to accuracy and detail, ability to work independently, ability to work under time pressure, prioritize, multi-task, and excellent communication skills both written and oral. |