Regulatory Start Up Associate II - AU
- Responsible for planning and preparing regulatory submissions for clinical trials.
- Serve as the primary contact for start-up activities and provide guidance on regulations.
- Ensure compliance with ICH-GCP guidelines and local regulatory requirements.
The Regulatory Start-Up Associate II (RSA), 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 II 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.
- RSA II
- At least 1 year Regulatory Start Up experience in clinical industry or equivalent experience in other roles in the Clinical industry.
- Graduate in a clinical, pharmacy or life sciences related field.
- Competent and productive and can perform a wide range of responsibilities within the Regulatory Start-Up function.
- Works independently with general supervision.
- Responsible for quality start-up deliverables at the country and site level; follows project requirements and applicable country rules, with minimal oversight from the RSM or PM.
- Provide mentorship to junior staff.
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