Regulatory Affairs Associate

• Join a supportive team with strong local leadership and global collaboration
• Collaborative and inclusive work environment
• Hybrid flexibility

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.

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.

• 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

• 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

Inclusive and supportive culture - our client believes in empowering their employees to make informed decisions and providing a collaborative environment for professional growth.

Click "Apply" or contact Gemma Staddon () for a confidential discussion.

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.

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