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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

Regulatory Affairs Associate

  • Sydney
  • Competitive salary package

Benefits: • Join a supportive team with strong local leadership and global collaboration • Collaborative and inclusive work environment • Hybrid flexibility   About the Company: Join a leading pharmaceutical organisation with a long-standing reputation for delivering high-quality therapies. You’ll be part of a local regulatory team that operates with autonomy, values deep technical expertise, and works closely with global partners to bring and maintain innovative medicines in the Australian market.   About the Opportunity: Step into a 12-month maternity leave contract as a Regulatory Affairs Associate with a strategic edge. This role combines hands-on lifecycle responsibilities with the opportunity to influence product strategy across a local portfolio. You’ll lead or support a mix of submissions — including Category 1, Category 3, SRRs, and complex CMC variations - while acting as the primary liaison with the TGA and key internal stakeholders. You’ll be given ownership of your work, backed by a high-performing team and an experienced manager.   Duties: • Prepare and manage Category 1 applications, including major variations and new indications • Lead Category 3 and SRR submissions as part of lifecycle management • Coordinate and deliver complex CMC variations • Manage GMP clearances and product site changes • Maintain local labelling, packaging, and artwork submissions • Partner with internal cross-functional teams and liaise directly with the TGA • Provide input into regulatory strategy for upcoming submissions or product changes • Support broader departmental initiatives and contribute to team-wide regulatory excellence   Skills and Experience: • Strong experience preparing Australian submissions across multiple categories • Demonstrated success leading or supporting Category 1 applications • Proficient in CMC variation submissions, post-approval changes and lifecycle maintenance • Excellent understanding of TGA processes and local regulatory requirements • Confident stakeholder manager – internally and externally • Life Sciences degree (or equivalent) essential   Culture: Inclusive and supportive culture – our client believes in empowering their employees to make informed decisions and providing a collaborative environment for professional growth.   How to Apply: Click "Apply" or contact Gemma Staddon (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.