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.
The Senior Specialist, GRA, will oversee Regulatory Affairs for commercial registration activities across the Asia-Pacific region at telix Pharmaceuticals. This role involves conducting regulatory tasks related to new product development, securing registrations, and managing the product lifecycle within the APAC markets.
What You’ll Do

• Manage our product lifecycle in Australia, encompassing shelf-life extension, incorporation of new manufacturing sites, and other major forthcoming changes in manufacturing. Additionally, overseeing the maintenance of GMP compliance for all manufacturing sites linked to Australian registrations.
• Providing support for the compilation of the NDA dossier for registration in the APAC region.
• Provide assistance to the Director of Regulatory Affairs by reviewing change controls, as well as quality and manufacturing data for global projects and multi-regional clinical trials.
• Efficient communication with the applicants, strategies preparation and presentation for institutions.
• Interfacing internally with QA, Clinical Development, Research and Innovation and other functions involved to ensure that dossiers are presented within the scheduled deadlines and that the material provided meets regulatory requirements.
• Maintain company Licences including new applications and renewals.
• Provide Regulatory, QA, technical and scientific information to all the business units and to other functional support departments where required.

About You

• Bachelor’s degree or higher in a Science field is highly regarded
• 8 years’ experience leading Regulatory Affairs in the Nuclear Medicine or Pharmaceutical environment (mandatory)
• Extensive experience in collaborating with the TGA in Australia
• Demonstrated knowledge of Quality Management Systems

At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
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