Assistant Regulatory Affairs – LATAM

🔥 12 minutes ago

🗣️🇪🇸 Spanish Required

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels • Pack and dispatch regulatory submissions, site contracts, and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools • Perform administrative QC of regulatory submissions, site documents and site contracts to ensure correct completeness and formatting • Liaise with Finance requesting fee payment to Regulatory Authorities. • Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action

🎯 Requirements

• 2 years office/business experience in a supporting role • Preferable CRO/pharmaceutical industry experience • Bachelor’s degree or equivalent preferred • Fluent in local language; working knowledge of English

🏖️ Benefits

• Committed to enabling professionals from all backgrounds and experiences to succeed • Diverse and inclusive environment that promotes collaboration and creativity

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