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Regulatory Affairs

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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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Check out our regulatory affairs content

Jobs in Regulatory Affairs.

Regulatory Affairs

Senior Technical & Regulatory Associate

  • Sydney
  • Competitive salary package & company benefits

Benefits • Permanent senior opportunity • Broad ANZ regulatory scope across medicines and medical devices • Collaborative, quality-driven environment with real influence   About the company This is a global healthcare organisation with an established presence across Australia and New Zealand. The business manages a sizeable and diverse portfolio and operates with a lean local team, offering individuals strong visibility and meaningful responsibility.   About the opportunity An experienced Senior Technical and Regulatory Associate is being appointed to support continued portfolio management and future growth. Reporting to the Regional Head, you’ll take ownership of a defined portfolio and manage it day to day with a high level of autonomy.   Duties • Support the Regional Head in managing departmental priorities • Prepare and maintain product and technical files across the portfolio • Manage new product registrations, variations and export registrations • Manage and liaise with local and international contract manufacturers • Review and approve promotional materials and product labelling • Develop and maintain compliant claims support • Provide technical and regulatory guidance to internal stakeholders   Skills and Experience • Bachelor of Science, Pharmacy or related scientific qualification • Demonstrated experience in Technical, Regulatory or QA roles within OTC pharma & Medical Device • Strong working knowledge of TGA requirements and GMP • Medical device regulatory experience required • Confident reviewing advertising and labelling in a regulated environment • Comfortable working autonomously while being a genuine team player • Clear communicator who enjoys collaborating cross-functionally   Culture You’ll be joining a pragmatic, high-trust team where expertise is valued and accountability matters.   How to Apply Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion.   About Healthcare Professionals Group Healthcare Professionals Group recruits across Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care, covering Medical Affairs, Regulatory, Quality, Commercial, Operations and Clinical Care roles at all levels.

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Regulatory Affairs

Pharmacovigilance and Regulatory Specialist

  • Melbourne
  • Competitive

Job Description Own post-marketing PI and CMI safety updates across AU & NZ portfolios Hands-on Pharmacovigilance & Regulatory Affairs role within a global generics organisation Permanent part-time | Fully remote | High-autonomy position About the Organisation Healthcare Professionals Group (HPG) is partnering with a globally established pharmaceutical organisation with a strong presence across Australia and New Zealand. Operating a diverse generics and hospital portfolio, the business is recognised for its commitment to regulatory compliance, product quality, and patient safety. With increasing portfolio complexity and ongoing regulatory requirements, the organisation is strengthening its local pharmacovigilance and regulatory capability to support post-marketing safety obligations across ANZ. About the Opportunity This is a hands-on Pharmacovigilance & Regulatory Affairs Specialist role focused on post-marketing safety and regulatory maintenance. Reporting into senior local leadership, you will take ownership of Product Information (PI) and Consumer Medicine Information (CMI) safety updates, ensuring ongoing compliance with TGA and Medsafe requirements across marketed and non-marketed products. The role is well suited to an experienced regulatory professional with strong generics and lifecycle management experience, comfortable working autonomously in a fully remote environment. While structured as a permanent part-time position (2–3 days per week), there is clear potential for additional scope and workload as the portfolio continues to evolve. Duties Own and deliver PI and CMI safety updates across Australian and New Zealand portfolios Conduct regular PI safety reviews against innovator reference safety information and global safety updates Manage TGA and Medsafe submissions related to PI and CMI updates within required regulatory timelines Review regulatory databases to identify safety-driven update requirements Support maintenance and ongoing compliance of the local pharmacovigilance system, including SOPs and safety agreements Address and close CAPAs arising from pharmacovigilance audits and inspections Perform monthly reconciliation activities to support PV system compliance Maintain accurate documentation and ensure ongoing adherence to ANZ pharmacovigilance requirements Skills and Experience Degree qualified in Life Sciences, Pharmacy, Nursing or a related discipline Minimum 3–5 years’ experience in Regulatory Affairs and/or Pharmacovigilance within pharmaceuticals Strong hands-on experience with PI and CMI lifecycle management and post-marketing variations Solid working knowledge of TGA and Medsafe regulatory frameworks Experience within generics or established product portfolios highly regarded Proven ability to work autonomously, manage timelines, and deliver accurate regulatory outputs Strong written communication skills and exceptional attention to detail Benefits Permanent part-time role (2–3 days per week) with flexibility Fully remote working arrangement High-autonomy position with ownership of critical regulatory activities Opportunity for role and scope expansion over time Supportive local leadership within a globally backed organisation Competitive base salary, pro-rated, plus super How to Apply To explore this opportunity in confidence, please contact: Rohan Lallbeeharry, Senior Recruitment Consultant, HPG | rlallbeeharry@hpgconnect.com | +61 485 860 660

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