Regulatory Affairs Assistant – Clinical Trial Maintenance

About the role

This entry‑level position supports the regulatory team in maintaining clinical trial approvals in Peru. The role involves preparing submissions, communicating with Ethics Committees and the national health authority (INS), and ensuring ongoing compliance of active studies.

Key responsibilities

• Prepare and file regulatory documents for trial amendments, safety reports, and study extensions.
• Interact with Ethics Committees and the Instituto Nacional de Salud (INS) on behalf of the sponsor.
• Monitor trial status and ensure all regulatory obligations are met throughout the study lifecycle.
• Maintain accurate records in document‑management systems and support internal reporting.

Required profile

• Graduated pharmacist or other health‑related professional (bachelor’s degree).
• 6–12 months of experience or internships in clinical trial or regulatory environments.
• Intermediate or higher English proficiency; Spanish used internally.
• Proactive, adaptable and comfortable working in a small, dynamic company.

Required skills

• Familiarity with basic clinical trial regulatory processes.
• Experience with submissions to Ethics Committees and national health authorities (preferred but not required).
• Proficiency with standard productivity and document‑management tools.

What we offer

• Hands‑on exposure to clinical trial regulatory activities in Peru.
• Strong learning and development opportunities.
• Collaborative environment with potential for long‑term career growth in regulatory affairs.