Regulatory Start Up Associate II

5 days ago

Australia Novotech Full time $90,000 - $120,000 per year
Description

About the Role

The Regulatory Start Up Associate, (RSA), 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.

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 submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required
  • 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.
  • Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required.
  • Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents.

 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 to you
  • 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. 

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. 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 clinical research and biotech, including people 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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