Director - DDC

The Regulatory Start Up Associate 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 Australia and we offer hybrid working arrangements (2 days in the office). 

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 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 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.
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