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.