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