Manager, Global Regulatory Affairs, Japan
Manager, Global Regulatory Affairs, Japan
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Job Description
See Yourself at Telix
To support the Groups 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
- Bachelors 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
Required Experience:
Exec
Employment Type
Full Time
