Job Details
Posted 12 November, 2026
Job Id: 632454
Regulatory Submissions (Study Start-Up) Manager in Melbourne
Job Description
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 strong 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.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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