Regulatory Hub Manager Position

1 day ago

Sydney, New South Wales, Australia beBeeManager Full time $150,000 - $180,000
Regulatory Hub Specialist Role

The Regulatory Hub Specialist manages end-to-end regulatory dossiers for multiple regions, focusing on initial registration and ongoing lifecycle management until product withdrawal.

This role involves maintaining portfolio phases from initial applications through the commercial lifecycle to product withdrawal.

  • Maintains portfolio phases from initial applications through the commercial lifecycle to product withdrawal.

Key responsibilities include timely delivery of local M1 dossier components, acting as the initial contact point for assigned cluster/countries, providing regulatory support for cross-functional activities, and supporting audit readiness activities.

Assists country strategists with cross-functional meetings on launch plans and performs quality review/approval of dossier build tables of contents. Partners with growth submission managers and regional hubs to deliver growth applications and support international commercial priorities.

Coordinates with labeling hubs on label and artwork updates and assists with simple HA query responses and coordination with SMEs for complex queries.

Apply technical expertise to impact business results and lead regulatory support in challenging environments.

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