Regulatory Start-Up Associate

The Regulatory Start-Up Associate (RSA) and Regulatory Start-Up Lead (RSL) are responsible for the planning, preparation, and review of 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 that all submissions comply with ICH-GCP guidelines and local regulatory requirements to support timely trial approvals.
The RSA / RSL has an action-oriented mindset to proactively address challenges and advance start-up activities. The ability to balance stakeholders is essential, considering ethical, cultural, and organizational needs.

Responsibilities

Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) and/or sites for country and site level start up activities on allocated projects.

• Provide expertise and guidance to RSM/PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.

• Work within the scope of the Regulatory Start Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.

• Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.

• Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.

• May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities.

• Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. 

• Ensure submission packages are accurate and complete per local requirements.

• Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe.

• Follow submission, application to approval.

• May prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements.

• Perform country and site Informed Consent Form (ICF) customisation in line with local requirements.

• Initiate translation of submission documents as applicable and review translated documents before submission.

• Support Clinical Contracts Specialists (CCS) to review and finalise the Country Master budget.

• Adapt site budgets from Country Master budgets and coordinate site budgets and Clinical Trial Agreement (CTA) negotiations with sites and/or CCS for finalisation and approval from PM/RSM and client if required.

• Review and approve proposed packaging and labelling for clinical trial material.

• Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required.

• Register project onto an official clinical trial registry as agreed to with Client and update status as required.

Serve mentor to junior team members and as a back-up line manager.

Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• At least 1-2 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment.