Manager, Global Regulatory Affairs, Japan

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 To support the Group's strategic objectives, the Regulatory Affairs Manager, Japan will oversee Regulatory Affairs for clinical and commercial registration activities of Telix portfolio in Japan. This role involves conducting regulatory tasks related to new product development, securing registrations, and managing the product lifecycle in Japan. This role will provide comprehensive support for clinical and commercial registrations across global, while also assisting the Senior Director – Regulatory APAC and Precision medicine. Key Accountabilities

• Develop and manage effective working relationships with the PMDA, MHLW, and other local health authorities, Telix Regional and other key stakeholders including Regulatory, QA, and Clinical Development, Project Management and to other functional support departments (e.g. Pharmacovigilance, Finance, Supply Chain).
• Make decision for regulatory strategy on each project in the team from perspective.
• Support in the preparation of regulatory dossiers for submission to PMDA, MHLW, and other local health authorities in order to obtain registration of the product.
• Provide tactical and strategic regulatory leadership to the team and manage all regulatory programs, including new product introduction, continuous improvement activities and/ or compliance related projects.
• Lead the regulatory and support vendors on planning and follow-up at consultation meetings, CTN, and NDA.
• Efficient communication with the applicants, strategies preparation and presentation for institutions (e.g. PMDA, MHLW, and other local health authorities).
• 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.
• Maintain the transparently between Regional (APAC) Regulatory/QA and PMDA, MHLW, and other local health authorities communications.
• Provide Regulatory, QA, technical and scientific information to all the business units and to other functional support departments where required.
• Regulatory files preparation and updating, including administrative and technical documents for new and modified products and/ or for eventual submissions to PMDA, MHLW, and other local health authorities
• Participate in the development or implementation of clinical trial protocols.

Education and Experience

• Bachelor’s degree (science) minimum
• Extensive experience in collaborating with the PMDA.
• 10+ years’ experience leading Regulatory Affairs in the Nuclear Medicine or Pharmaceutical environment
• Experience working in a PMDA/MHLW-regulated environment
• Demonstrated knowledge of Regulatory and ICH guidelines.
• Strong experience with CTD/eCTD submissions in clinical and commercial regulatory filings.
• Fluency in Japanese highly desirable

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. VIEW OUR PRIVACY POLICY HERE Apply tot his job Apply To this Job