At a Glance
- Tasks: Manage ethics and regulatory submissions for clinical trials, ensuring compliance with guidelines.
- Company: Join a leading organisation in the clinical research field with a focus on innovation.
- Benefits: Attractive salary, flexible work options, and opportunities for professional growth.
- Other info: Dynamic team environment with potential for career advancement.
- Why this job: Be at the forefront of clinical trials and make a difference in healthcare.
- Qualifications: Experience in regulatory processes and strong communication skills are essential.
The predicted salary is between 69300 - 84700 $ per year.
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 in Sydney employer: Novotech
Novotech is an exceptional employer that fosters a dynamic and collaborative work culture, perfect for those passionate about advancing their careers in toxicology and regulatory affairs. Located in Australia, we offer our employees comprehensive growth opportunities, competitive benefits, and the chance to work alongside industry experts on cutting-edge projects in clinical trials. Join us to make a meaningful impact in the field while enjoying a supportive environment that values innovation and professional development.
