Regulatory Start Up Manager

Novotech; Melbourne; On-site; AUD 80,000 - 100,000; Full time

Benefits offered by this job

Flexible working options

Parental leave for both parents

Wellness programs

Job summary

A leading contract research organization in Melbourne is seeking a Regulatory Start Up Manager. In this role, you will manage the regulatory start-up strategy across various regions, ensure compliance with local regulations, and oversee project progress. Ideal candidates will have a degree in a relevant field and at least 3 years of experience in trial start-up processes. This organization supports flexible working options and promotes an inclusive workplace.

Qualifications

• 3+ years of experience in CRO or pharmaceutical trial start-up.
• Experience managing start-up processes across multiple regions.
• Thorough knowledge of applicable regulations.

Responsibilities

• Define and manage the Regulatory Start Up strategy.
• Ensure compliance and collaboration with local teams.
• Oversee submission processes to health authorities.

Skills

Project Management

Regulatory Knowledge

Communication Skills

Problem-Solving

Education

Degree in Clinical, Pharmacy or Life Sciences

Job description

Overview

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• 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 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 up and escalate to Project Manager.
• Provide timely update of regulatory start up progress to Project Manager.
• Present at external and internal meetings including but not limited to project internal and external meetings, kick-off 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.
• Through 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.

Employer overview: Novotech is committed to an inclusive work environment where everyone is treated fairly and with respect. We support flexible working options, parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are an equal opportunity employer and encourage applications from people of all backgrounds, including those who identify as LGBTIQ+, have a disability or have caring responsibilities. We respond to every application as part of our Circle Back initiative.