HPG Regulatory Affairs Recruitment

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Regulatory Affairs professionals play a crucial role in ensuring that each product is developed, manufactured, and marketed in compliance with regulations, thereby safeguarding overall public health and promoting patient safety.

Welcome to the HPG page dedicated to Regulatory Affairs recruitment. At HPG, we specialise in connecting exceptional professionals with rewarding healthcare jobs, including pivotal roles in regulatory affairs.

Our expert recruitment team focuses on identifying top-tier talent for regulatory affairs jobs, ensuring our clients benefit from professionals who are instrumental in maintaining compliance and upholding the highest standards in healthcare. From regulatory affairs jobs that involve navigating complex legislation to roles that ensure product safety and efficacy, we cover the full spectrum of regulatory support.

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Are you looking for a fulfilling career in regulatory affairs within the healthcare sector? HPG is here to help you find the perfect opportunity. We offer a wide range of regulatory affairs jobs, from entry-level positions to advanced roles that require specialised knowledge and experience. Whether you're interested in working as a regulatory affairs specialist, compliance manager, or regulatory consultant, we have the connections and expertise to match you with employers who value your skills and contributions.

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Jobs in Regulatory Affairs.

Regulatory Affairs,Executive Roles

Country Head, Regulatory Affairs, ANZ

Melbourne
Attractive salary package including equity on joining

Once-in-a-career regulatory leadership opportunity Pioneer the regulatory landscape for innovative medicines in Australia Market-leading remuneration including substantial equity on appointment About the company Healthcare Professionals Group is proud to partner with one of the pharmaceutical sector’s most dynamic and transformational organisations - a company that has played a pivotal role in saving lives and improving health outcomes for patients globally. With an expanding pipeline, this organisation has genuinely exciting and ambitious plans for Australia and the region. This is a company where you don’t follow the regulatory guideline, you help build it. Where the work you do will shape how Australia’s health authorities approach an entirely new class of medicines. And where being part of a lean, high-calibre team means extraordinary breadth of exposure and genuine impact. About the opportunity As the senior regulatory leader for Australia and New Zealand, you will define and drive local regulatory strategy in alignment with global priorities. You’ll be operating at the intersection of strategic leadership, health authority engagement, and one of the most exciting manufacturing stories in Australian healthcare. This is not a standard affiliate regulatory head role. Melbourne is home to this organisation’s manufacturing facility, a significant and ongoing regulatory responsibility that sets this position apart from a typical ANZ affiliate regulatory head. You will play a central role in the regulatory oversight of that facility, including site licensure, GMP compliance and lifecycle management, as the organisation continues to develop its local manufacturing capability with a view to supplying the Australian and export markets. You will serve as the primary interface with the Therapeutic Goods Administration and Medsafe, leading high-impact negotiations, scientific advice discussions, and the shaping of regulatory pathways for innovative platforms. Your ability to build and maintain senior relationships with health authorities - negotiating with credibility, engaging as a genuine partner, and knowing when to push and when to give - will be central to your success. You will lead a small, capable internal team and a well-established network of specialist external vendors, providing the senior regulatory direction and strategic positioning the team needs to operate at its best. You will also sit on the ANZ leadership team and represent Australia and New Zealand in global regulatory forums. Reporting to the regional regulatory head, and working closely with the ANZ General Manager, this is a role with genuine global visibility and local accountability. Key responsibilities Define and lead ANZ regulatory strategy across the product lifecycle, ensuring alignment with global priorities and optimal local outcomes Serve as primary interface with TGA and Medsafe - leading high-impact engagements, scientific advice discussions and negotiation of regulatory pathways Provide regulatory leadership and strategic oversight for the Melbourne manufacturing facility, including site licensure, GMP inspection readiness and ongoing lifecycle management Oversee planning, preparation and execution of regulatory submissions and lifecycle activities across development and marketed products Contribute to shaping the external regulatory environment through engagement with health authorities, industry associations and policy forums, particularly advancing frameworks for innovative biopharmaceutical platforms Provide regulatory input to support local research and clinical collaborations Lead, develop and direct the local regulatory team and external vendor network Represent ANZ in global regulatory and cross-functional forums, advocating for regional needs and influencing global decision-making Partner with the ANZ GM and cross-functional teams including Clinical, Quality, Manufacturing, Medical and Commercial to support product development and launch Identify, assess and proactively manage regulatory risks, aligning strategies with business objectives Skills & experience The following experience is essential: Degree in Life Sciences or related discipline; advanced degree preferred (PharmD, MSc, PhD or equivalent) Extensive regulatory affairs experience within pharma, with significant time in regulatory strategy Demonstrated senior leadership experience including building, leading and developing high-performing regulatory teams Strong knowledge of TGA regulatory frameworks and demonstrated success in senior TGA engagement and negotiation Proven track record leading major regulatory submissions and high-impact health authority interactions Experience with global regulatory frameworks (e.g. CTD) and their application across regions Familiarity with CMC regulatory requirements sufficient to engage credibly with technical experts and health authorities on manufacturing, quality and inspection matters Proven ability to operate in a global, matrixed organisation - influencing cross-functional teams and senior stakeholders The ability and appetite to operate as both a strategic leader and a hands-on contributor in a lean team environment Exposure to regulatory policy engagement and shaping of novel regulatory frameworks (preferred, not essential) Benefits Market-leading remuneration package including base salary, performance bonus and substantial new hire and annual equity Comprehensive health and wellbeing benefits Life and disability insurance Access to global teams, world-class science and a pipeline that is genuinely changing medicine How to Apply Click 'Apply' if you meet the essential skills and experience requisites, or contact Adrian McConchie, Director at amcconchie@hpgconnect.com or Jo Turner, Divisional Manager Life Sciences, at jturner@hpgconnect.com. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare — Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care: Medical Affairs & Life Sciences Recruitment — Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific Commercial Recruitment — Marketing, Sales, Analytics, Government and External Affairs Business Operations & Infrastructure Recruitment — Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain Clinical Care Recruitment — Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing For more job opportunities, visit www.hpgconnect.com

Director - Regulatory Affairs

Melbourne
$200000 - $250000 per annum

About the Role We are partnering with an established global biopharmaceutical organisation to appoint a Director, Regulatory Affairs for Australia and New Zealand. Based in Melbourne, this role sits within the company's Global Regulatory Affairs function and forms part of a broader regional team. This is a newly created leadership position offering a clear step-up to a regional remit. You will lead the local regulatory team, act as the primary external interface with local health authorities and industry bodies, and shape regulatory strategy across a diverse specialty portfolio. Key Responsibilities Lead and develop the local regulatory team, supporting day-to-day decision-making and acting as the first point of escalation. Build and grow a high-performing team, attracting talent and developing capability across the function. Serve as the primary interface with relevant health authorities, government bodies and industry associations. Develop and execute innovative regulatory strategies for new product registrations, lifecycle management and launches. Ensure strict compliance with local regulations, leading audit and inspection readiness. Partner closely with Commercial Operations, Medical and other cross-functional stakeholders to translate regulatory insight into actionable business plans. Provide expert review of promotional materials, labelling and product information in line with local legislation. Represent the organisation in industry forums and policy activities, sharing insights and best practice. About You 10+ years of regulatory affairs experience in the pharmaceutical or biotech industry, including significant time in a health-authority-facing role. Demonstrated leadership experience, including building and managing high-performing teams. In-depth knowledge of the Australian regulatory environment; New Zealand exposure highly regarded. Specialty biologics experience well regarded. Strong commercial acumen and a track record of working cross-functionally with Medical, Commercial and Pharmacovigilance teams. Excellent stakeholder management skills and the ability to influence at all levels in a complex, global matrix environment. Bachelor's degree in a relevant scientific discipline What’s on Offer Hybrid working arrangement based out of Melbourne. The opportunity to shape regulatory strategy for a globally significant portfolio. Genuine regional career progression within a respected regional team How to Apply Click Apply or contact Jo Turner at jturner@hpgconnect.com to arrange a confidential discussion

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