Manager, Regulatory Affairs

Develop regulatory strategy for new drug developments, Health Authority meetings, and Japan New Drug Submissions (J-NDA). Prepare Japanese Common Technical Documents (J-CTD) and arrange internal reviews. Lead preparation of Clinical Trial Notifications, major regulatory submissions, and responses to Health Authority questions with stakeholders. Ensure maintenance and compliance of regulatory activities for development and marketed products. Accountable for defining project strategy, timelines, and risk mitigation as the JAPC representative on GRT. Follow regulatory changes and competitor status to assess impacts on daily activities. Lead Japanese Package Insert Revision activities on Commercial and Medical Division requests. Requires at least 2 years in R&D or Regulatory field with native-level Japanese and TOEIC 800+ in English.