Senior Regulatory Labeling Manager – Clinical Trials (IMP)

Telix Pharmaceuticals Limited; Genf; Hybrid; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Telix Pharmaceuticals Limited seeks a Manager, Regulatory Affairs (Clinical Labeling) to oversee IMP labeling for global trials and ensure compliance with GMP, GCP, EU CTR, Annex VI and FDA requirements.

The role partners with Regulatory Affairs, Clinical Operations, Quality, and external vendors to manage labeling documents across the clinical development lifecycle and across regions, including translation coordination and change control. Hybrid/remote options available.

Qualifications

• Bachelor's degree in life sciences required.
• Minimum 5 years’ experience in pharmaceutical regulatory affairs, global labeling, clinical, or clinical operations; at least 2 years in IMP labeling.

Responsibilities

• Leads creation, revision, review, agreement and maintenance of IMP labeling for Telix’s investigational products.
• Collaborates with Regulatory Affairs, Clinical Operations, Quality and external partners for input, review and approval.
• Ensures label content reflects protocol requirements, product characteristics, storage conditions and country-specific requirements.
• Ensures compliance with local and regional laws and regulations (EU CTR, Annex VI/13, FDA, GxP).
• Provides labeling expertise during protocol development, study start-up, amendments, and country expansion.
• Coordinates translation and verification of multilingual labeling content.
• Manages version control and change management for labeling documentation.
• Supports submission or notification of IMP labeling where required.
• Evaluates new regulatory requirements and industry trends impacting labeling.
• Supports regulatory inspections and audits with labeling documentation.
• Acts as regulatory point of contact for IMP labeling; identifies improvements for processes and templates.
• Assists with other labeling activities and projects as needed.

Skills

Regulatory affairs

Labeling

Global labeling

IMP labeling

Cross-functional collaboration

GMP/GCP knowledge

Veeva (desirable)

MS Office

Education

Bachelor's degree in life sciences

Tools

Veeva

Microsoft Office

Job description

Telix Pharmaceuticals Limited seeks a Manager, Regulatory Affairs (Clinical Labeling) to oversee IMP labeling for global trials and ensure compliance with GMP, GCP, EU CTR, Annex VI and FDA requirements.

The role partners with Regulatory Affairs, Clinical Operations, Quality, and external vendors to manage labeling documents across the clinical development lifecycle and across regions, including translation coordination and change control. Hybrid/remote options available.