Position Summary
The Senior Manager, Regulatory Affairs serves as the Japan regulatory lead for assigned development projects. This role is responsible for formulating and executing Japan regulatory strategies in alignment with global development plans, leading PMDA interactions, and ensuring high‑quality regulatory submissions including CTNs, J-NDAs, and J-sNDAs.
As a senior regulatory expert, the individual will provide strategic input to cross‑functional teams, guide regulatory risk assessment and mitigation, and contribute to the successful and timely delivery of medicines to patients in Japan.
Role & Responsibilities
Develop and implement Japan regulatory strategies for development programs and new indications, ensuring alignment with global regulatory strategies.
Serve as the regulatory representative on project teams, providing expert guidance on Japan regulatory requirements.
Lead preparation and executi...