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Regulatory Affairs

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

Senior Regulatory Affairs Associate

  • Sydney
  • Competitive salary package

Benefits • Excellent opportunity for progression and development opportunities • Work with a global specialty pharmaceutical company • Collaborative culture with a strong focus on quality and innovation   About the company Part of a leading global specialty pharmaceutical group with a strong presence across the APAC region. The business is committed to improving patient access to important medicines and maintains high standards for quality, compliance and cross-regional collaboration.   About the opportunity We are seeking a Senior Regulatory Affairs Associate to join a high-performing team. Reporting to the Regulatory Director, you will support product registration and variation activities, dossier compilation and publishing, and submission tracking across the region. You will build strong working relationships with cross-functional teams and external partners to ensure timely, compliant delivery of submission activities.   Duties • Prepare and manage product registration and variation submissions in line with local regulatory requirements • Conduct gap analyses to ensure dossier compliance prior to submission • Develop and review product labelling, product information and consumer information in collaboration with Medical and Marketing teams • Coordinate dossier compilation and electronic publishing activities across the region • Maintain GMP evidence and ensure timely pre-clearance for manufacturing sites where required • Support due diligence activities for potential new product acquisitions • Manage incoming/outgoing agency correspondence and communicate outcomes to stakeholders in a professional and timely manner • Maintain submission tracking, regulatory documentation and compliance with internal SOPs and QMS standards • Contribute to continuous improvement and a quality-focused mindset within the team   Skills and Experience • Bachelor’s degree in Science or a related discipline • Minimum 4 years’ experience servicing the Australia/New Zealand region or similar markets • Strong written and verbal communication skills and a good eye for detail • Proactive, organised and able to manage competing priorities • Comfortable working cross-functionally in a fast-paced environment   Culture The organisation encourages collaboration, ownership and continual learning. The team values quality and teamwork and provides opportunities for professional growth.   How to Apply If this sounds like a fit, please click apply or contact Gemma Staddon on +61 2 8877 8776 for a confidential discussion.  

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Regulatory Affairs

Regulatory Affairs Specialist

  • Sydney
  • Competitive salary package

Benefits • Great opportunity to step into a busy, hands on regulatory role • Work with a high performing global organisation  • Supportive and collaborative team environment About the company This is an established global player recognised for its strong portfolio of trusted brands and long standing commitment to quality. With a focus on research, product innovation, and continuous improvement, the business maintains a strong presence across multiple markets while keeping a people-focused culture at the centre. About the opportunity This role offers the chance to take ownership of key regulatory activities on a parental leave contract. You’ll lead TGA submissions for OTC medicines and medical devices, support lifecycle management, and partner closely with cross functional teams including R&D, Quality, and Marketing. It’s a varied and fast paced position suited to someone who enjoys rolling up their sleeves and working autonomously. Duties • Prepare, submit, and manage TGA regulatory submissions for medical devices and registered OTC medicines • Maintain up to date knowledge of regulations, standards, and market requirements • Liaise with regulatory authorities and manage responses to queries • Support lifecycle management including variations, renewals, and compliance activities • Review and approve product labelling, advertising, and promotional materials • Compile regulatory dossiers and lodge new product and change applications • Collaborate with internal teams to ensure compliance across operations Skills and Experience • Tertiary qualifications in science, pharmacy, or a related field • Demonstarted regulatory affairs experience across pharmaceuticals, medical devices, or FMCG • Strong understanding of TGA frameworks • Excellent attention to detail with strong organisational and communication skills • Confident managing multiple priorities and working independently Culture The organisation fosters a supportive and inclusive culture built on collaboration, accountability, and innovation.  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 across Pharma, Biotechnology, Medical Technology and Clinical Care including: • Medical Affairs and 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 and Infrastructure Recruitment – Administration, Customer Service, Engineering, Finance, Human Resources, IT, L and 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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