Director, Global Regulatory Affairs CMC Japan

The Team Lead, Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team.

Reporting to the Head of Global Regulatory Affairs CMC you will partner closely with Global Regulatory Affairs CMC, Japan Regulatory Affairs, Global Regulatory Affairs and Safety, R&D, Manufacturing, Technical Operations, and Quality

stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio.

Define Japan-relevant regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s product portfolio and represent CSL in official regulatory CMC capacities, acting as responsible person in interactions with regulatory agencies, specifically PMDA and MHLW.

Your main respon...