Global Regulatory Labeling Manager, Clinical Trials

Telix Pharmaceuticals Limited; United States; Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Equity-based incentive program

Generous vacation

Wellness days

Learning and development support

Job summary

Telix Pharmaceuticals is seeking a Manager, Regulatory Affairs (Clinical Labeling) to oversee IMP labeling for global clinical trials. You will ensure compliance with GMP, GCP, EU CTR, and FDA requirements, and coordinate with Regulatory Affairs, Clinical Operations, Quality, and external vendors.

The role involves developing and maintaining labeling documents, managing translations, version control, and supporting submissions.

Qualifications

• Minimum 5 years’ experience in pharmaceutical regulatory affairs, global labeling, clinical operations.
• At least 2 years in IMP labeling (Clinical Labeling).
• Experience supporting IMP labeling across multiple regions and regulatory jurisdictions.
• Strong understanding of GMP, GCP, EU CTR, Annex VI, Annex 13, and FDA IMP requirements.

Responsibilities

• Lead creation and maintenance of IMP labeling across products.
• Collaborate with Regulatory, Clinical Ops, Quality and external vendors for input, review and approval of IMP labeling.
• Ensure label content reflects approved protocol requirements and country-specific rules.
• Support submissions and translations; manage version control and change management.

Skills

Regulatory affairs

Clinical labeling

GMP/GCP knowledge

Cross-functional collaboration

Veeva knowledge

MS Office

Education

Bachelor's degree in life sciences

Tools

Labeling management systems

Veeva

Job description

Telix Pharmaceuticals is seeking a Manager, Regulatory Affairs (Clinical Labeling) to oversee IMP labeling for global clinical trials. You will ensure compliance with GMP, GCP, EU CTR, and FDA requirements, and coordinate with Regulatory Affairs, Clinical Operations, Quality, and external vendors.

The role involves developing and maintaining labeling documents, managing translations, version control, and supporting submissions.