Position Overview 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. Solid planning and alignment skills ensure activities are structured and adaptable to change.

Responsibilities - Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.

- Participate in company start‑up initiatives, contributing to development and maintenance of Regulatory Start‑Up processes, tools and SOPs.



Identify areas of inefficiency in process and make recommendations for improvements.
- Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs.
- Serve as the local subject matter expert on specialised aspects of regulatory and start‑up activities.

Experience Requirements - At least 3 years Regulatory Start‑Up experience in the local clinical industry.

Qualifications - Graduate in a clinical, pharmacy or life sciences related field.

Benefits We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

EEO Statement We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. Job Information - Job Identification: 4206

- Posting Date: 07/12/2026, 09:40 PM
- Job Schedule: Full time
- Location: Level 19, 66 Goulburn Street, Sydney, New South Wales, 2000, AU

📌 Senior Regulatory Start Up Associate (Australia)
🏢 Life Sciences WA
📍 Australia