Manager, Global Regulatory Affairs

Summary

Join Telix Pharmaceuticals as their Regulatory Affairs Manager, Japan, and oversee regulatory affairs for clinical and commercial registration activities of Telix's portfolio in Japan. This role involves conducting regulatory tasks related to new product development, securing registrations, and managing the product lifecycle in Japan. You will provide comprehensive support for clinical and commercial registrations globally, assisting the Senior Director – Regulatory APAC and Precision Medicine. The position requires extensive collaboration with the PMDA, MHLW, and other local health authorities. You will be part of a supportive team with a shared purpose of improving the lives of people with cancer and rare diseases. Telix offers competitive salaries, bonuses, an equity-based incentive program, generous vacation, paid wellness days, and support for learning and development.

Requirements

• 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

Responsibilities

• 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

Preferred Qualifications

Fluency in Japanese highly desirable

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development