Starpharma is an innovative Australian biotechnology company located in inner Melbourne. With three decades of experience advancing dendrimer technology from the lab to the patient, our mission is to help patients with significant illnesses, such as cancer, achieve improved health outcomes and quality of life through the application of our unique dendrimer technology.

Through our innovative R&D; and strategic partnerships with leading pharmaceutical companies, we are developing therapies that have the potential to profoundly improve patient health worldwide.

Working at Starpharma offers the reward of contributing to the broader community. You will be part of a team creating medical device and pharmaceutical products that have the potential to positively impact people around the world. You will work closely with other talented and committed professionals who share a common focus. We take pride in offering a great culture, qualified working environment, attractive remuneration package including an employee incentive program, Health & Wellbeing program, and the opportunity to continue developing your career as part of a small team in the dynamic biotech industry.

Starpharma has achieved Great Place to Work® certification for four consecutive years, and in 2026 was named in the top 10 list of Best WorkplacesTM in Biotechnology & Pharmaceuticals in Australia. We're proud to be recognised for the positive, inclusive and high-trust culture we've built. Being named a Best WorkplaceTM recognises Starpharma as an organisation setting a high standard for workplace culture and employee experience in Australia. Just as importantly, we're committed to continuing to listen, learn and evolve,



creating a workplace where talented people can do their best work and enjoy being part of the Starpharma team.

The Position

This is a full-time, 12-month contract position reporting to the Regulatory Affairs Manager. You will contribute to the management of regulatory affairs related to the company's discovery, development and commercial activities. You will ensure that pharmaceutical and medical device products are developed and delivered in full and on time, approved in relevant regions and maintained in accordance with regulatory requirements and the commercial objectives of the company.

Key responsibilities include:

Contributing to the development and preparation of regulatory strategies to support Starpharma's R&D; and commercial programs

Managing and delivering regulatory projects/activities in support of required development and commercialisation outcomes including timelines. Also independently managing assigned regulatory projects, including planning, execution, timelines and cross-functional coordination

If required, identifying and managing appropriate regulatory consultants, potentially including regional authorised representatives and agents

Contributing to the preparation of regulatory submissions for products (device/drug/other) to agreed timelines, ensuring completeness, quality and alignment with applicable regulatory requirements

Maintaining registrations and ensuring adherence to reporting requirements.



Also monitoring regulatory obligations and proactively managing timely submission of variations, renewals and reporting requirements

Managing project meetings and coordinating maintenance of project/design documentation, as required

Identifying and managing regulatory affairs-related service providers where necessary to support activities

Maintaining Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) for medical device products, ensuring documentation is accurate, complete and compliant with applicable regulatory and quality requirements

Preparing and maintaining Technical Files / CTDs. Also reviewing and critically assessing technical documentation to ensure scientific and regulatory adequacy

Contributing to periodic updates to Clinical Evaluation documentation for Starpharma's medical devices

Contributing to management of the medical device risk management program, and identifying, analysing and managing risks associated with areas of responsibility and expertise

Contributing to management of the post market surveillance and vigilance programs, including preparing and maintaining risk assessments, Periodic Safety Update Reports (PSUR), and Post-Market Clinical Follow-up (PMCF) Evaluation Reports

Contributing to the review of product marketing and promotional materials, including labelling, for compliance with relevant regulatory and advertising requirements

Participating in regulatory audits and other audits as required. Also supporting audit readiness activities and responding to audit findings within areas of responsibility

Interpreting applicable regulatory requirements and providing guidance to cross-functional stakeholders to ensure

📌 Senior Regulatory Affairs Associate (Melbourne)
🏢 Starpharma
📍 Melbourne