Manager, Regulatory Affairs

We're hiring an experienced Regulatory Affairs Manager to join Global Regulatory Affairs in Melbourne, working across CSL Seqirus manufactured products in Asia Pacific, including influenza vaccines and Products of National Significance (PNS) such as snake/spider antivenoms.

This role offers regional regulatory strategy ownership, meaningful Health Authority engagement, and exposure to both high-volume and high-criticality products.

Reporting to the APAC/LATAM Regulatory TA Lead Vaccines and as part of a close knit team, you will:

• Drive and implement APAC regulatory strategy for CSL Seqirus manufactured products, including development activities and complex technical/lifecycle changes
• Lead regional regulatory input to dossiers and submissions, including direct interaction and negotiation with Health Authorities
• Prepare and manage high-quality submissions (MAAs, variations, renewals, HA questions) across CSL Seqirus territories
• Partner cross-functionally to anticipate and manage regulatory risks and priorities
• Ensure regulatory compliance and traceability via appropriate management of submissions and agency correspondence
• Provide leadership for regional labelling strategy and execution, driving consistent, high-quality and compliant outcomes across CSL Seqirus territories
• Build and maintain strong Health Authority relationships across the region

• Tertiary qualification in biological science, allied medical discipline or pharmacy
• 7+ years' regulatory affairs experience, including Asia Pacific submissions
• Prior experience in negotiating with the local Health Authorities, preparing, filing and driving regulatory submissions, including marketing authorisation applications, to approval
• Prescription Medicine (PoM) regulatory experience (vaccines preferred)
• Strong stakeholder management skills and ability to operate in a global matrix environment comprising a range of different functional areas and cultures
• Knowledge of device requirements would be a distinct advantage.