Regulatory Start Up Manager
Novotech · AU
The Regulatory Start Up Manager is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by par...
Job description
About the Role The Regulatory Start Up Manager is primarily responsible to plan, drive and coordinate operational aspects of regulatory and start-up across a region, by partnering with the Project Manager to ensure project deliverables are met within agreed project timelines and in accordance with client’s expectations. Responsibilities: - Define a Regulatory Start Up (RSU) strategy and prepare an RSU management plan. - Oversee the execution of regulatory start up for assigned projects in accordance with agreed RSU strategy. - Ensure collaboration with local regulatory start up teams to successfully deliver the agreed project scope in compliance with the RSU management plan. - Distribute start up related documents to local regulatory start up teams. - Oversee customization of core start-up documents to local requirements. - Ensure preparation and distribution of core contract and budget templates to applicable team members. - Oversee submission processes to health authorities, ethics committees and other review bodies. Provide regional coordination for meeting approval timelines. - Oversee site activation package compilation and approvals. - Proactively identify any risks to start...