Regulatory Start-Up Manager or Sr. Manager (Australia & New Zealand)

Role/Function Summary:

The Regulatory and Study Start-Up Specialist is responsible for leading and coordinating regulatory and study start-up activities for Sironax-sponsored clinical trials across Australia and New Zealand. This role supports study activation from feasibility through site initiation, ensuring all regulatory, ethics, governance, contractual, and operational requirements are completed in accordance with applicable regulations, ICH-GCP, company procedures, and study timelines.

The successful candidate will work closely with Clinical Operations, Project Management, Medical, Regulatory, investigators, study sites, ethics committees, governance offices, vendors, and regulatory authorities to ensure efficient and compliant study start-up and site activation activities.

This position requires strong knowledge of Australian and New Zealand clinical trial regulations, including TGA, CTN/CTA schemes, HREC, SSA/RGO, ANZCTR, Medsafe, Health and Disability Ethics Committees (HDEC), and Medicines Australia contracting frameworks.

Responsibilities and Duties:

• Lead and coordinate study start-up activities from protocol finalisation through site activation.
• Prepare, submit, track, and maintain Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) applications and associated regulatory documentation.
• Prepare and coordinate Human Research Ethics Committee (HREC) submissions, amendments, annual reports, safety reports, protocol deviations, and study closure notifications.
• Prepare and coordinate Site Specific Assessment (SSA), Research Governance Office (RGO), and governance submissions for Australian study sites.
•  Support Medsafe notifications and Health and Disability Ethics Committee (HDEC) submissions for New Zealand clinical trials.
• Prepare, submit, maintain, and update Australian New Zealand Clinical Trials Registry (ANZCTR) registrations throughout the study lifecycle.
•  Coordinate site feasibility activities and support site identification and selection processes.
• Collect, review, and maintain essential regulatory and study start-up documentation.
• Develop and maintain study-specific start-up plans, trackers, timelines, and activation strategies.
• Track ethics approvals, governance approvals, contracts, budgets, and site activation milestones.
• Identify, document, and escalate start-up risks and delays that may impact study timelines.
• Liaise with HRECs, governance offices, regulatory authorities, investigators, study coordinators, and site administrators to facilitate timely approvals and study activation.
• Support preparation, review, negotiation, tracking, and execution of Clinical Trial Research Agreements (CTRAs), confidentiality agreements, indemnities, site agreements, and other study-related contracts.
• Coordinate with legal, finance, investigators, governance offices, and internal stakeholders to facilitate timely contract execution.
• Support development, review, and negotiation of site budgets in collaboration with Clinical Operations and Finance.
• Maintain contract and budget trackers and provide regular updates to study teams.
• Ensure all contractual and regulatory documentation is complete, accurate, and maintained in accordance with company procedures and Trial Master File (TMF/eTMF) requirements.
• Support onboarding and coordination of vendors involved in study start-up activities.
• Participate in study team meetings and provide updates on regulatory, governance, contract, budget, and activation status.
• Support internal audits, sponsor audits, inspections, and quality assurance activities as required.
• Maintain inspection-ready documentation and contribute to quality and compliance initiatives.
• Contribute to the development and continuous improvement of study start-up processes, SOPs, templates, trackers, and work instructions.
• Review and QC all submissions
• Archive all submissions
• Update study document tracker as appropriate

Educational Requirements

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Health Sciences, or a related discipline.

Other Requirements

• Full legal working rights in Australia are required.

Experience:

• Minimum 3–5 years' experience in Clinical Research, Regulatory Affairs, Study Start-Up, Clinical Operations, or a related clinical research role.
• Demonstrated experience preparing and coordinating CTN and/or CTA submissions.
• Demonstrated experience preparing and coordinating HREC, SSA, and RGO submissions.
• Experience maintaining and updating ANZCTR registrations.
• Experience supporting site activation activities from feasibility through site initiation.
• Experience supporting Clinical Trial Research Agreements (CTRAs), confidentiality agreements, indemnities, site agreements, and site budget negotiations.
• Experience working with investigators, study coordinators, ethics committees, governance offices, sponsors, CROs, and vendors.
• Strong working knowledge of ICH-GCP and Australian clinical trial regulations.
• Familiarity with Medsafe and HDEC requirements for New Zealand clinical trials is highly desirable.
• Experience within oncology, metabolic, obesity, rare disease, or early-phase clinical trials is advantageous. 

Other Skills and Abilities:

• Strong understanding of Australian and New Zealand clinical trial regulations and requirements.
• Working knowledge of:

o   Therapeutic Goods Administration (TGA)

o   CTN and CTA Schemes

o   NHMRC National Statement

o   Human Research Ethics Committee (HREC) requirements

o   SSA and RGO processes

o   Australian New Zealand Clinical Trials Registry (ANZCTR)

o   Medsafe clinical trial requirements

o   Health and Disability Ethics Committee (HDEC) requirements

o   Medicines Australia Clinical Trial Research Agreement (CTRA) framework

·        Strong project coordination and organisational skills.

·        Excellent attention to detail and documentation management skills.

·        Strong written and verbal communication skills.

·        Ability to manage multiple studies and competing priorities simultaneously.

·        Strong stakeholder management and relationship-building skills.

·        Ability to identify, assess, and proactively mitigate risks.

·        Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

·        Experience using CTMS, eTMF, regulatory tracking systems, and other clinical trial management tools.

·        Ability to work collaboratively within cross-functional teams and external stakeholder groups.