My client is a large multinational healthcare company with its products, therapies, and digital health solutions available in more than 100 countries.
They are currently looking for 2 Regulatory Leads, Pharmaceuticals and Medical Devices in Japan.
Location: Tokyo
Role: Regulatory Lead - Medical Device
Responsibility:
Registration and maintenance of Device
- Input global necessary requirements on RA through project team meeting from Japan regulatory perspectives
- Plan and execute Registration strategy and schedule
- Participate and contribute Core Team meeting for R&D project. Be an active member of Japan project team with a good relationship/communication with global counterparts and Business (by attending Teleconference with Global team) in collaboration with global counterparts, prepare answers to PMDA queries for completion of PMDA review process.
- Assess regulatory impact as SME (Subject Matter Expert) on change request of On-Market products, and maintain these regulatory compliances by appropriate actions
Requirements:
- Background in Scientific (Physical/Chemical) or Pharmaceutical
- Experience in device registration (3 years).
- Experience to prepare STED
- Experience and/or knowledge of filing with ARCB or category for "with clinical trial", QMS inspection/MDSAP, PSE mark, Giteki mark and Measurement Act will be advantageous
- Native Japanese and fluent English
Role: Regulatory Lead - Pharmaceutical
Responsibility:
Registration and maintenance of Pharmaceutical Drugs
- Input global necessary requirements on RA through project team meeting from Japan regulatory perspectives
- Plan and execute Registration strategy and schedule
- Participate and contribute Core Team meeting for R&D project. Be an active member of Japan project team with a good relationship/communication with global counterparts and Business (by attending Teleconference with Global team) in collaboration with global counterparts, prepare answers to PMDA queries for completion of PMDA review process.
Requirements:
- Background in Scientific (Physical/Chemical) or Pharmaceutical
- Experience in new drug registration (3 years).
- Experience to prepare document registration for PMDA
- Native Japanese and fluent English
For further information about this position please apply.
