The Regulatory Start Up Associate II, (RSA II), is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval.
This role will be based in our Sydney or Melbourne offices and hybrid working options are available. Responsibilities: Serve as the primary point of contact for the Regulatory Start Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects.
Provide direction and leadership to project CRA's.Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices.Prepare and submit Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required.Work within forecasted submission/approval timelines and ensure they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.Prepare and submit import/export license applications and manage licenses and customs clearance thereafter if required.Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensure accuracy and completeness of these documents.Minimum Qualifications & Experience: Knowledge of local ethics and regulatory processes and overall study start-up process.Tertiary qualifications in clinical or life sciences related field.Solid knowledge of GCP, national and international regulations and a sound understanding of how they apply.Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments.Novotech is proud to offer a great workplace.
We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development programs.
We are looking for people who are passionate about working in clinical research and biotech, including those who identify as LGBTIQ+, have a disability, or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.
We look forward to contacting you regarding your application.
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