Scientific & Regulatory Specialist

CMA is seeking a self-motivated individual to join the association to help strengthen the role of the organisation in advancing the complementary medicines sector by educating, exercising influence, and developing technical proposals in the realm of scientific policy, regulation and public health.

This is a full-time role. A reduced pro-rata working arrangement for the right candidate may be considered.

You will be part of a small, collaborative team who all share a passion for advancing complementary medicines in Australia. We offer great staff benefits including work-from-home, a supportive team environment, not-for-profit salary packaging benefits, a paid leave scheme over Christmas and New Year, and various networking, professional development and travel opportunities.

About Complementary Medicines Australia

Complementary Medicines Australia (CMA) is the peak industry body for the $6.3 billion complementary medicines sector in Australia, representing businesses throughout the supply chain. Complementary medicines encompass vitamin and mineral supplements, targeted nutritional and herbal therapeutics based on modern scientific trials, as well as traditional medicines that are based on generations of cultural use across the globe. Complementary and traditional medicines are recognised as fundamentally important to integrate into health systems worldwide by the World Health Organization.

CMA collaborates with the Therapeutic Goods Administration (TGA) and other government agencies to develop and uphold effective, balanced regulatory standards for these products. CMA advocates for improved consumer access to high-quality complementary medicines and seeks opportunities to foster innovation, industry growth and Australia’s competitive advantage in global markets.

About the role

This position will be to strengthen CMA’s scientific and regulatory capability to help achieve practical, positive change for the complementary medicines industry. We welcome applicants with substantial expertise in clinical research methodology and efficacy evidence, preferably with phytopharmaceutical or microbiological knowledge.

Working within a small team, you will largely lead your own projects with the support of CMA and our industry members, as well as actively support the broader work of CMA’s regulatory team.

You will bring strong knowledge and a demonstrated passion for the complementary medicines sector, with a determination to turn sound clinical and scientific analysis into meaningful outcomes for industry.

The role requires initiative and the ability to develop creative but credible regulatory proposals to complex scientific and regulatory problems. In consultation with our members, you will recognise opportunities where improvements to policy, guidance or legislation need to be pursued as well as critically analyse the potential impacts of new Government proposals. You will question established approaches and have the confidence to constructively address complex issues with the key regulator – the Therapeutic Goods Administration.

Location

Remote (work from home). Short periods of semi-regular travel to attend staff in-person days, CMA industry events and professional conferences is required.

Essential qualifications and capabilities

• A relevant tertiary qualification in clinical research, epidemiology, pharmacology, microbiology, biomedical science, pharmacy, herbal or complementary medicine, nutrition, or a related discipline.
• Demonstrated ability to critically appraise scientific literature and explain the strengths, limitations and practical implications of the evidence and its methodologies.
• Substantial expertise in at least one of the following two areas:
• Clinical research and efficacy: advanced understanding of clinical trial design and methodology, interpretation of statistical findings, evidence synthesis and the applicability of study results to products and populations.
• Biotics: substantial scientific or technical expertise in one or more relevant areas, with the ability to assess clinical evidence and explain how ingredient or preparation characteristics, manufacturing and quality affect its interpretation and use.
• Sound scientific judgement, including the ability to identify uncertainty, challenge unsupported conclusions and recognise when additional expertise is needed.
• The ability to understand stakeholder concerns and develop practical responses to advocate strongly for industry while maintaining scientific integrity.
• Excellent analytical writing, including the ability to develop a clear, well-supported position from complex or conflicting information.
• A demonstrated highly effective and proactive communication style with colleagues, industry members, researchers and Government stakeholders.
• Experience in Australia’s complementary medicines regulatory framework relating to safety and efficacy, including the Listed, Assessed Listed, and Registered medicine pathways and their evidence requirements.
• The ability to be self-organised, manage competing priorities, demonstrate resilience, and commit to maintaining momentum within a challenging environment is essential.

Desirable experience and knowledge

• A research qualification such as Honours, a research Masters or a PhD.
• Experience in or a passion for translating scientific evidence into regulatory assessments, policy proposals, technical advice or industry submissions, and a strong drive to bring positive change.
• Experience working within a regulatory environment for medicines or foods.
• Understanding of pharmacovigilance principles and relevant adverse event data sources, such as the TGA’s Database of Adverse Event Notifications (DAEN).
• Awareness of international regulatory developments (for example, from Health Canada or the European Food Safety Authority) and emerging areas such as artificial intelligence and real-world data in complementary medicine research.

Key responsibilities

1. Assess scientific evidence. Critically review clinical studies and other relevant literature, examining methodological quality, consistency, clinical relevance and applicability to the ingredient, preparation, product or proposed use.
2. Develop scientific and regulatory positions. Prepare technical briefs, consultation responses and proposals that explain the evidence, address regulatory concerns and identify practical options for industry. Correspond with government officials on regulatory and commercial matters affecting industry.
3. Take responsibility for regulatory outcomes. Progress CMA’s work plan on a range of issues, particularly complex issues relating to the safety and efficacy assessment of complementary medicines, including nutrients, herbal medicines, and biotic preparations.
4. Assess scientific evidence and safety signals. Critically review clinical studies, literature and pharmacovigilance/adverse event data, examining methodological quality, consistency, clinical relevance and applicability to the ingredient, preparation, product or proposed use, drawing on additional expertise where needed.
5. Develop scientific and regulatory positions. Prepare technical briefs, consultation responses, proposals and submissions to Government that explain the evidence, address regulatory concerns and identify practical options for industry. Correspond with government officials on regulatory and commercial matters affecting industry.
6. Progress complex regulatory matters. Take responsibility for progressing complex safety and efficacy matters across nutrients, herbal medicines and biotic preparations, from evidence review through to resolution.
7. Secretariat role and industry collaboration. Perform the lead secretariat role for CMA’s Scientific Advisory Working Group. You will work with senior academics and industry scientific advisors to advance CMA’s scientific representation. You will also work in a secretariat role for other groups in a lead or supportive role, as required. Outside of the secretariat role, you will collaborate directly with a wide range of CMA members, Government officials and academics to progress the work of CMA.
8. Manage priorities and monitor developments. Agree priorities with the regulatory team, deliver work to deadlines, and monitor emerging research and regulatory developments — domestic and international — that warrant CMA's attention.
9. Represent CMA in technical discussions. Contribute to relevant CMA committees, working groups and discussions with the TGA, researchers and other stakeholders. Work with members to understand technical constraints, evidence gaps and the practical effects of regulatory proposals.
10. Actively contribute to member advancement. You will help to inform and update CMA’s membership base on a wide range of regulatory and scientific issues, through developing written materials and presenting short speeches or workshops. Respond to member enquiries within your expertise and actively support CMA's commitment to the ethical and responsible promotion of complementary medicines.
11. Other duties. Undertake other relevant duties as directed, consistent with skills, competence and training.