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.

Quality Assurance,Regulatory Affairs

Senior Associate, Quality Assurance & Regulatory Affairs

Sydney
Competitive salary + company benefits

Benefits Permanent opportunity within an international pharmaceutical company Broad role across both Regulatory Affairs and Quality Assurance Work closely with local, regional and global stakeholders About the company A global pharmaceutical organisation with an established Australian presence and a strong commitment to quality, compliance and patient outcomes. About the opportunity An exciting opportunity has become available for a Senior Associate, Quality Assurance & Regulatory Affairs to join an international pharmaceutical organisation. This is a broad, hands-on position covering both Regulatory Affairs and Quality Assurance. You will support regulatory submissions and lifecycle activities across Australia and New Zealand, while also contributing to the ongoing management of the Quality Management System, GMP compliance and broader quality activities. This would suit someone with established pharmaceutical RA and/or QA experience who enjoys working across both functions and is looking for broader responsibility and exposure. Duties Prepare, submit and manage regulatory applications to the TGA and Medsafe Support regulatory activities throughout pre-submission, submission and evaluation Coordinate responses to Health Authority questions and requests Maintain regulatory dossiers, submission records and product-specific documentation Support ARTG applications, variations, renewals and ongoing product lifecycle activities Review Product Information, labels, artwork, packaging and related materials for compliance Assess regulatory impact of manufacturing, supplier, formulation, packaging and testing changes Support TGA GMP clearances, including applications, renewals and supporting documentation Maintain and support Quality Management System activities including deviations, CAPAs, change controls and complaints Support supplier qualification, vendor compliance and quality agreements Assist with product quality reviews, recalls, investigations and batch release activities Support audit, inspection and compliance readiness Skills and Experience Tertiary qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, Microbiology or a related discipline 3 to 5 years' experience within pharmaceutical Regulatory Affairs or Quality Assurance Experience supporting or managing regulatory submissions Knowledge of TGA regulatory requirements, with Medsafe exposure highly regarded Good understanding of GMP requirements and pharmaceutical quality systems Experience across QMS activities such as deviations, CAPAs, change controls or complaints advantageous Experience within a pharmaceutical sponsor, manufacturer or distribution environment highly regarded Strong attention to detail and documentation skills Strong organisation and time management skills with the ability to manage competing priorities Excellent communication and stakeholder management skills Ability to work independently while collaborating effectively across teams Culture Join a collaborative and quality-focused environment where you will work across multiple areas of the business and have the opportunity to broaden your Regulatory Affairs and Quality Assurance experience. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. 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, Warehouse; Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

Director - Regulatory Affairs

Melbourne
Attractive salary + benefits on offer

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

Regulatory Affairs Manager ANZ

Sydney
Competitive salary package

Benefits • ANZ leadership role with genuine strategic influence • Lead and develop an established Regulatory Affairs team • Broad exposure across new registrations, lifecycle management and portfolio growth • Join a growing healthcare business with an expanding portfolio and pipeline About the company This established healthcare organisation operates across Australia and New Zealand, partnering with a broad range of products and businesses across the pharmaceutical sector. With continued growth across the region, the business offers a fast-moving and commercially focused environment where Regulatory Affairs plays an important role in portfolio strategy, new opportunities and successful product launches. About the opportunity An exciting opportunity has become available for an experienced Regulatory Affairs leader to take responsibility for the ANZ regulatory function. Leading a small team, you will oversee regulatory strategy and execution across Australia and New Zealand while remaining close to key submissions, new registrations and complex regulatory projects. This is broader than a traditional Regulatory Affairs management position. You will work closely with senior leadership, commercial teams and external partners to assess new opportunities, shape regulatory strategy and provide guidance around pathways, timelines, risk and feasibility. The role would suit someone who enjoys leading people but still wants to remain connected to the technical and strategic side of Regulatory Affairs. Duties • Lead, coach and develop the Regulatory Affairs team • Set priorities and oversee regulatory workload across the portfolio • Develop regulatory strategies for new product registrations and lifecycle activities • Provide oversight of submissions to the TGA and Medsafe • Support new registrations, variations, transfers and post-approval activities • Lead complex or business-critical regulatory projects • Provide regulatory input into new product opportunities, portfolio expansion and business cases • Assess regulatory pathways, timelines, risks and resource requirements for prospective opportunities • Partner with Commercial, Medical Affairs, Quality, Pharmacovigilance, Supply Chain and Business Development • Build strong relationships with external partners and provide strategic regulatory advice • Support regulatory aspects of product launches, manufacturing changes and artwork updates • Contribute to regulatory process improvement, compliance and inspection readiness • Monitor team resources, project requirements and regulatory service delivery • Contribute to broader ANZ leadership discussions and business planning Skills and Experience • Extensive pharmaceutical Regulatory Affairs experience across the Australian market • Strong knowledge of TGA regulatory requirements and ideally experience across New Zealand/Medsafe • Demonstrated experience managing new registrations as well as ongoing lifecycle activities • Previous people leadership experience, including coaching and developing regulatory professionals • Comfortable remaining hands-on and providing technical guidance when required • Strong understanding of regulatory strategy and the commercial implications of regulatory decisions • Strong stakeholder management skills with the confidence to work with senior internal and external stakeholders • Able to manage multiple priorities within a changing and commercially focused environment • Proactive, solutions-focused and comfortable taking ownership Culture Join a collaborative and agile environment where Regulatory Affairs has strong visibility across the wider business. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. 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, Warehouse • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing

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