Assistant Regulatory Affairs - Remote

Worldwide Clinical Trials is a global midsize CRO dedicated to innovative approaches in clinical research to improve lives. They are seeking a Regulatory Affairs support role to assist with regulatory submissions, documentation, and coordination across multiple regions.

Location: Remote (LATAM)

Responsibilities

• 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