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 prospect 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.
- Robust 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 team-oriented 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 (Melbourne)
🏢 Planet Pharma Group
📍 Melbourne