Associate Director, Global Regulatory Affairs - Remote

Overview

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.

In Short

• Responsible for ensuring regulatory objectives align with corporate objectives.
• Execute global regulatory strategy and dossier compliance.
• Prepare and execute global regulatory strategies for assigned projects.
• Provide regulatory expertise to product development teams.
• Lead regulatory agency interactions and prepare meeting documentation.
• Monitor global health authority regulations for compliance.
• Lead regulatory interaction for IND and BLA filings.

Requirements

• Undergraduate degree in a scientific field required; Advanced degree preferred.
• 9+ years’ experience in regulatory affairs for pharmaceuticals required.
• Direct experience in writing regulatory sections for global health authority applications.
• Experience in radiopharmaceuticals and clinical development preferred.
• Knowledge of drug development process and GMP.
• Experience working globally in the US and EMEA.

Benefits

• Competitive salaries and annual performance-based bonuses.
• Equity-based incentive program.
• Generous vacation and paid wellness days.
• Support for learning and development.