Global Clinical Labeling Manager (IMP) – Hybrid

Telix Pharmaceuticals (AMER); Australia; Hybride; CAD 90 000 - 120 000; Plein temps

Résumé du poste

Telix Pharmaceuticals seeks a Manager, Regulatory Affairs (Clinical Labeling) to develop, maintain, and oversee IMP labeling for global clinical trials. You will ensure compliance with GMP, GCP and country-specific requirements while supporting supply chain timelines.

You will partner with Regulatory Affairs, Clinical Operations, Quality and external vendors to manage labeling documents, translations, and version control across regions including the US, EU, UK, Canada and Asia-Pacific.

Qualifications

• Minimum 5 years in pharmaceutical regulatory affairs, with 2+ years in IMP labeling.
• Experience supporting IMP labeling for multi-region clinical trials.
• Strong knowledge of regulatory frameworks and labeling requirements.

Responsabilités

• Lead creation, revision and maintenance of IMP labeling according to protocol and region.
• Collaborate with Regulatory Affairs, Clinical Ops, Quality and vendors for labeling input and approvals.
• Ensure label content reflects protocol, product specs, storage and country needs.
• Manage version control and change management for labeling documents.
• Support labeling submissions and country expansion activities; coordinate translations.

Connaissances

Regulatory affairs

Global labeling

GxP knowledge

Communication

Team collaboration

Formation

Bachelor’s degree in life sciences

Outils

Microsoft Office

Labeling management systems

Veeva (desirable)

Description du poste

Telix Pharmaceuticals seeks a Manager, Regulatory Affairs (Clinical Labeling) to develop, maintain, and oversee IMP labeling for global clinical trials. You will ensure compliance with GMP, GCP and country-specific requirements while supporting supply chain timelines.

You will partner with Regulatory Affairs, Clinical Operations, Quality and external vendors to manage labeling documents, translations, and version control across regions including the US, EU, UK, Canada and Asia-Pacific.