Regulatory Affairs Manager

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. 

See Yourself at Telix

The Manager, Regulatory Affairs (Clinical Labeling), is responsible for the development, maintenance, and oversight of Investigational Medicinal Product (IMP) labeling (also referred to as “Clinical Labeling”, “Special Access Scheme labeling”, “Compassionate Use labeling”, “Early Access Program labeling”, etc.) for Telix’s investigational products used in global clinical trials. This role ensures that all IMP labeling complies with applicable global regulatory requirements, Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs), and company standards while supporting supply chain execution and study timelines.

The Manager, Regulatory Affairs (Clinical Labeling), serves as a key cross-functional partner to Regulatory Affairs, Clinical Operations, Quality, and other internal stakeholders and external vendors to develop and manage labeling documents that support investigational products throughout the clinical development lifecycle. Provides strategic direction and operational oversight for IMP labeling activities throughout the product development lifecycle, partnering with the Senior Director, Regulatory Affairs (Labeling/Ad-Promo).

Key Accountabilities:

• Leads the creation, revision, review, agreement, and maintenance of Investigational Medicinal Product (IMP) labeling (also referred to as “Clinical Labeling”, “Special Access Scheme labeling”, “Compassionate Use labeling”, “Early Access Program labeling”, etc.) and Calibration Labeling for Telix’s investigational products.
• Collaborates with internal stakeholders (e.g., Regulatory Affairs, Clinical Operations, Quality) and external partners (e.g., Contract Research Organizations, Contract Manufacturing Organizations, translation vendors, artwork vendors, packaging vendors) for input, review and approval of IMP labeling.
• Ensures label content accurately reflects approved protocol requirements, product characteristics, storage conditions, and country-specific requirements.
• Ensures regulatory compliance with applicable local and regional laws and regulations and internal policies governing IMP labeling, including requirements for the United States, European Union, United Kingdom, Australia, Canada, Asia-Pacific, and other participating countries. These requirements include, but are not limited to, EU Clinical Trial Regulation (CTR) and Annex VI requirements, EU GMP Annex 13 requirements, U.S. FDA requirements, ICH GCP guidelines, and country-specific IMP labeling requirements.