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.

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📌 Regulatory Start Up Associate II - AU (Sydney)
🏢 Novotech
📍 Sydney