Manager, CMC Regulatory Affairs
Core
Lead regulatory CMC activities for CTN, J-NDA, and eCTD supplement submissions in Japan, acting as a liaison with the PMDA.
Role type
Manager, CMC Regulatory Affairs
Builds
Regulatory dossiers and submissions for life-changing medicines
Domain
Biopharmaceuticals / Japanese Regulatory Affairs
Deliverable
client delivery
Required skills
CMC regulatory strategy, PMDA interaction, submission planning, scientific writing, change control assessment, manufacturing process review, foreign manufacturing accreditation management
Preferred skills
Master's degree in science, strategic thinking
Technologies
eCTD, CTN, J-NDA, PCA, MCN
Responsibilities
Lead planning and critical review of CTN, J-NDA, and eCTD supplement submissions; Prepare Japanese application forms and support regulatory dossiers; Act as local liaison with PMDA for CMC submissions; Assess CMC change controls against regulatory filings; Review manufacturing processes and specifications against approved filings; Participate in agency meetings.
Seniority
Manager, hands-on IC
