Regulatory Start-Up Associate II

About the role

The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) plan, prepare and review country- and site-level ethics and regulatory authority submissions during the start-up phase of clinical trials, and where applicable throughout maintenance and close-out. They ensure submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals. This posting describes the RSA II level.

Key responsibilities

• Serve as the main point of contact for the Regulatory Start-Up Manager, Project Manager and sites on allocated projects, and guide them on country and local regulations and practices.
• Prepare and submit Central EC/IRB, local EC, Regulatory Authority and other local regulatory or site submissions, ensuring packages are accurate and complete, and follow up on comments from reviewing bodies.
• Follow submission, application to approval, and prepare ongoing amendments, notifications, safety reports and study materials as required.
• Customise Informed Consent Forms locally, initiate translation of documents and review translations before submission.
• Support Clinical Contracts Specialists in reviewing the Country Master budget, adapt site budgets and coordinate Clinical Trial Agreement negotiations.
• Review and approve packaging and labelling for clinical trial material, and handle import/export licence applications and customs clearance if needed.
• Register the project on a clinical trial registry, maintain the trial master file and escalate delays to the RSM/PM with a contingency plan.
• Mentor junior staff and contribute to start-up processes, tools and SOPs.

Required profile

• At least 1-3 years of regulatory start-up experience in the clinical industry, or equivalent experience in another clinical role.
• Competent and productive, able to work independently with general supervision.
• Graduate in a clinical, pharmacy or life sciences-related field.
• At least 1-2 years of related experience in a CRO, pharmaceutical or clinical/hospital environment.