Senior Manager, Regulatory Affairs
Core
Japan regulatory lead for assigned development projects, formulating and executing Japan regulatory strategies in alignment with global development plans.
Role type
Senior Manager, Regulatory Affairs
Builds
Japanese regulatory submissions (CTN, J-NDA, J-sNDA) and strategies for new medicines
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Japan regulatory strategy, PMDA interactions, CTD/eCTD preparation, cross-functional coordination, risk assessment, stakeholder management
Preferred skills
Drug development process knowledge, negotiation, independent problem-solving, influencing without authority
Technologies
CTD, eCTD, J-CTD
Responsibilities
Develop and implement Japan regulatory strategies for development programs; Lead preparation and execution of PMDA Consultation Meetings; Coordinate cross-functional contributions for submissions; Represent Japan regulatory perspectives within global regulatory teams; Ensure compliance with Japan regulatory requirements; Act as key point of contact for PMDA and MHLW
Seniority
Senior Manager, strategic leadership with hands-on execution