Manager, Kite Regulatory Affairs CMC
Core
Lead Japan regulatory strategy and execution for cell and gene therapy products across development and post-approval stages.
Role type
Manager, Regulatory Affairs (CMC)
Builds
Regulatory dossiers, marketing applications, and change notifications for cell and gene therapy products in Japan.
Domain
Biopharmaceuticals / Cell and Gene Therapy / Japan Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory dossier preparation, ICH guidelines knowledge, Japan regulatory strategy, risk assessment, stakeholder liaison, compliance with Cartagena Act, regulatory submission review
Preferred skills
PhD or MS, relevant industry experience, industry association participation
Technologies
None stated
Responsibilities
Lead Japan regulatory strategy and execution; Prepare and maintain regulatory dossiers; Support pre-clinical regulatory consultations; Lead marketing and change applications; Serve as liaison for GCTP compliance inspections; Build relationships with PMDA; Conduct risk assessments on regulatory issues; Stay current on Japan regulatory requirements
Seniority
Manager, hands-on IC
