Regulatory Submissions (Study Start-Up) Manager
Melbourne, Australia
Mid-Sized CRO
Overview
An established mid-sized Contract Research Organisation (CRO) is seeking an experienced
Regulatory Submissions (Study Start-Up) Manager
to join its Clinical Operations team in Melbourne.
This role offers the opportunity to lead study start-up activities across Australia and the wider APAC region, supporting the successful delivery of global clinical trials and working closely with sponsors on regulatory strategy.
Location & Working Arrangement
South Yarra, Melbourne
Primarily office-based environment
Hybrid flexibility available following successful completion of probation and tenure milestones
Benefits
Structured career development and advancement opportunities
Comprehensive onboarding and training programme
Ongoing professional development and learning opportunities
Collaborative, team-focused working environment
Company-sponsored social and networking events
Comprehensive employee benefits package
Key Responsibilities
Lead and oversee all aspects of global study start-up activities across assigned projects.
Provide strategic regulatory guidance to sponsors and project teams.
Develop proactive solutions to study start-up challenges and submission timelines.
Prepare, review, and approve informed consent forms and regulatory documentation.
Conduct quality reviews of submission packages and essential site documentation.
Coordinate regulatory submissions to ethics committees and health authorities where required.
Support bid defence meetings, capability presentations, audits, and sponsor interactions.




Collaborate closely with Clinical Operations, Project Management, and cross-functional stakeholders to ensure efficient study activation.
Required Experience
Bachelor's degree in Health Sciences, Life Sciences, Pharmacy, Nursing, or a related discipline.
Minimum 5 years' experience leading regional study start-up activities within a CRO environment.
Strong knowledge of clinical trial regulations and submission processes across Australia and APAC.
Experience working with regulatory authorities such as TGA and/or Medsafe.
Excellent written and verbal communication skills in English.
Proven ability to manage multiple studies and stakeholders simultaneously.
Preferred Experience
Broader APAC regulatory submission experience.
Previous experience in Clinical Research Associate (CRA), Study Start-Up, Regulatory Affairs, or Project Management roles.
Experience supporting multinational or global clinical trials.
What We're Looking For
The successful candidate will be a proactive and detail-oriented clinical research professional who enjoys working in a fast-paced environment.
You will have robust leadership skills, a collaborative approach, and the ability to navigate complex regulatory requirements while driving study start-up timelines forward.
Why Join?
Support innovative clinical research programmes across the APAC region.
Work within a high-performing and collaborative team.
Gain exposure to global studies and international stakeholders.
Benefit from structured career progression and professional development.
Contribute directly to bringing new therapies to patients faster.
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📌 Regulatory Submissions (Study Start-Up) Manager In Melbourne
🏢 Planet Pharma Group
📍 Melbourne