Global Regulatory Start-Up Lead

Life Sciences WA; City of Melbourne; Hybrid; AUD 90,000 - 140,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Flexible leave entitlements

Wellness programs

Professional development programs

Job summary

Novotech is a global full-service clinical CRO seeking a Regulatory Start Up Manager to plan, drive and coordinate RSU activities across regions. You will partner with the Project Manager to ensure timely, compliant deliverables and seamless collaboration with local RSU teams, health authorities, and ethics committees.

The role requires a clinical/life sciences background with 3+ years in trial start-up/regulatory operations, excellent English, and strong planning, documentation, and

Qualifications

• Graduate in a clinical, pharmacy or life sciences-related field.
• At least 3 years’ experience from a CRO or the pharmaceutical industry in trial start-up/regulatory operations.
• Thorough knowledge of applicable regulations.
• Able to manage in a matrix environment.
• Confident decision-making and problem-solving.
• High proficiency in English.

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 RSU strategy.
• Ensure collaboration with local regulatory start up teams to deliver the agreed project scope.
• Distribute start up documents to local RSU teams and customize core templates as needed.
• Oversee submission processes to health authorities, ethics committees and other bodies.
• Provide regional coordination to meet approval timelines.
• Oversee site activation package compilation and approvals.
• Identify risks to start up and escalate; develop RSU mitigation plans.
• Provide timely updates of RSU progress to the Project Manager.
• Present at internal and external meetings; act as client contact for RSU items.

Skills

Regulatory start-up

Stakeholder management

Presentation skills

Decision making

Problem solving

Education

Bachelor's degree in life sciences/clinical/pharmacy

Job description

Novotech is a global full-service clinical CRO seeking a Regulatory Start Up Manager to plan, drive and coordinate RSU activities across regions. You will partner with the Project Manager to ensure timely, compliant deliverables and seamless collaboration with local RSU teams, health authorities, and ethics committees.

The role requires a clinical/life sciences background with 3+ years in trial start-up/regulatory operations, excellent English, and strong planning, documentation, and