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Biotech • Pharmaceutical • 3PL: Third Party Logistics • Manufacturing
Manage contract lifecycle for a pharmaceutical contract service organization: coordinate signing, filing, tracking, and templates; monitor negotiations and approvals; flag risks; liaise with legal counsel, clients, suppliers, and internal teams; maintain contract database and ensure compliance with quality systems.
Biotech • Pharmaceutical • 3PL: Third Party Logistics • Manufacturing
Support regulatory operations for pharmaceutical clients: conduct regulatory surveillance, manage licenses and controlled-substance compliance, assist with CMC and submission documentation (IND/NDA/BLA/DMF), coordinate audits and audit responses, author procedures, support change notifications, and provide regulatory guidance to internal teams and clients to ensure compliance with FDA, EMA, MHRA, ICH and other requirements.



