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Regulatory Start Up Manager

2 weeks ago

Brisbane, Queensland, Australia Novotech Full time

Overview
Join to apply for theRegulatory Start Up Managerrole atNovotech
Be among the first applicants to apply for this role.
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 the RSU strategy.
Collaborate with local regulatory start up teams to 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 risks to start up and escalate to the Project Manager.
Provide timely updates on regulatory start up progress to the Project Manager.
Present at external and internal meetings including project kick-off and other meetings.
Experience and Qualifications
Graduate in a clinical, pharmacy or life sciences related field.
Experience managing start up in more than one country and/or region.
At least 3 years' experience from a CRO or the pharmaceutical industry in activities related to trial start-up and/or regulatory operations.
Thorough knowledge of applicable regulations.
Able to manage in a matrix environment.
Confident decision-making and problem-solving.
Strong presentation, documentation, and people skills.
High proficiency in English.
Company and Benefits
Novotech is 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 with flexible working options, parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are a Circle Back Initiative Employer and commit to respond to every application.
Seniorities and Employment Type
Mid-Senior level
Full-time
Job function
Project Management and Research
Industries
Biotechnology
Research and Professional Services
We are looking for people who are passionate about working in clinical research and biotech, including individuals who identify as LGBTIQ+, have a disability or have caring responsibilities.
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