Senior Regulatory Affairs Associate

Starpharma Pty Ltd; Melbourne; On-site; AUD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive remuneration with cash &?/

Health & wellbeing program

Professional development opportunities

Job summary

Starpharma is an innovative Australian biotechnology company in inner Melbourne seeking a Regulatory Affairs professional to support regulatory activities across discovery, development and commercialization of pharmaceutical and medical device products.

You will develop regulatory strategies, prepare submissions, maintain registrations, and guide cross‑functional teams to ensure compliance with global regulatory requirements.

Qualifications

• Minimum 5 years’ experience in regulatory affairs for medical devices or pharmaceuticals.
• Knowledge of applicable regulatory requirements (ISO 13485, EU MDR, FDA) for development, registration and commercialization.
• Excellent analytical and attention to detail.
• Strong teamwork, collaboration and communication skills.
• Organisational skills with ability to maintain detailed records.
• Willingness to update knowledge and stay current with regulatory changes.

Responsibilities

• Develop and implement regulatory strategies to support Starpharma's R&D and commercial programs.
• Lead and manage regulatory projects, timelines and cross‑functional coordination.
• Identify and engage regulatory consultants or agents when required.
• Prepare regulatory submissions for devices/drugs to meet timelines and quality standards.
• Maintain registrations and monitor reporting, variations and renewals.
• Support regulatory audits and ensure compliance across activities.

Skills

Regulatory affairs

Cross‑functional work

Regulatory strategy

Project management

Education

BSc in Biological Sciences

Job description

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, professional 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 Workplaces™ 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 Workplace™ 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 compliance in project activities.

Other expectations

Collaborating and working effectively with others in support of achieving corporate objectives:

• • Interacting respectfully and constructively, sharing information appropriately, with proactive cross-functional involvement, acknowledging efforts and contributions of others, demonstrating willingness to give and receive constructive feedback, role modelling effective problem solving, contributing to project and team unity, and discussing and clarifying priorities where required
  • Collaborating with other teams and relevant others in support of achieving Company goals and enhancement of a high-performance culture
  • Providing regular updates on progress against objectives and milestones.

STAR Values and Behaviours

In addition to the specific requirements for this role, STAR values and behaviours we look for in all employees are:

Superior performance

• Persevering and going the extra mile when it is needed
• Effectively prioritising and working with a sense of urgency
• Ensuring quality and accuracy

Teamwork

• Collaborating and teaming in an effective, solution-focused way with others to achieve desired outcomes
• Using a respectful and clear communication style which supports and encourages teamwork across the company and facilitates optimal business outcomes
• Having a positive energy, and a "can do" and optimistic attitude for oneself and in influencing others

Accountability

• Taking ownership of our actions and decisions
• Reviewing situations and decisions to harvest the learnings for future benefit (lessons learned)
• Being honest and doing what we say we will do
• Being willing to remedy unintended consequences of actions or decisions, where appropriate

Re-imagination

• Demonstrating curiosity, being open to and taking the initiative to generate new ideas
• Identifying problems and generating potential solutions, taking account of costs/benefits and risks/opportunities through a commercial and strategic lens
• Showing flexibility and adaptability

Benefits

• Highly respected employer – Great Place to Work® certified and named in the top 10 Best Workplaces™ in Biotechnology & Pharmaceuticals in Australia
• Small, committed team
• Professional, collegial environment
• Competitive remuneration including cash and equity-based incentives
• Fantastic health and wellbeing program with a wide range of activities for social, physical & mental wellbeing, plus EAP
• Support for professional development including access to high-quality online learning resources

Candidate Profile

Applications must explicitly address the following key selection criteria:

• Candidates must have Australian work rights at the time of application.
• A minimum of BSc in Biological Sciences, Chemistry, Biochemistry, Pharmacy or related field, with higher degrees valued
• At least 5 years’ prior experience in a medical device or pharmaceutical commercial regulatory setting
• Knowledge and/or experience in applicable regulatory requirements (e.g., ISO 13485, EU MDD, EU MDR, UK MDR, TGAC, TG(MD), ICH, FDA 21 CFR, GLP, GMP) for the development, registration and commercialisation of medical devices and/or pharmaceuticals
• Excellent analytical acumen and attention to detail
• A work style characterized by diligence and a strong work ethic
• Personal attributes of flexibility and responsiveness
• Strong teamwork, collaboration, respectful communication and interpersonal skills
• Strong organisational skills including the ability to keep detailed records
• Enthusiastic about acquiring new skills and maintaining currency of knowledge of pharmaceutical and medical device regulatory requirements.

Want to apply for this job?

If applying for this role, please include a cover letter that outlines:

1. why this role is of interest to you

2. why you are looking for a change from your current job, and

3. how you line up against the key selection criteria in the Candidate Profile.

Note that applications without the cover letter addressing the points above will not be considered.

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