Regulatory & Study Start‑up Analyst I (Remote – Argentina)

About the role

Intrials is seeking a Regulatory & Study Start‑up Analyst I to support clinical trial start‑up activities for its Argentine operations. The role is fully remote and focuses on navigating regulatory pathways, managing study supplies, and ensuring compliance with local and international standards.

Key responsibilities

• Coordinate regulatory affairs submissions to Local Ethics Committees, Central Ethics Committees, the Ministry of Health and other review bodies.
• Manage importation, storage, shipment, return and destruction of investigational product and clinical trial materials.
• Prepare and submit safety reports to the Ministry of Health when required.
• Ensure compliance with SOPs, work instructions, local and international regulations, and ICH‑GCP.
• Represent Intrials as a legal representative before regulatory authorities, if needed.
• Collaborate with Project Managers to define regulatory and importation strategies and track document approvals.
• Maintain close communication with sites, sponsors, vendors and regulatory agencies to obtain and submit required documentation.

Required profile

• Experience in regulatory affairs for clinical trials, preferably within a CRO environment.
• Familiarity with Argentine regulatory bodies, ethics committees and Ministry of Health processes.
• Strong organizational skills and ability to manage multiple study start‑up tasks simultaneously.
• Excellent written and verbal communication in English.

Required skills

• Regulatory affairs for clinical trials
• Study supply logistics (import/export, storage, shipment)
• ICH‑GCP compliance
• Ethics committee submission processes
• Document preparation and tracking