ManagerⅡ,RA TA Group, Regulatory Affairs(Oncology)
Core
Execute regulatory affairs activities for oncology projects, ensuring timely submission of documents to PMDA/MHLW and supporting global regulatory strategy.
Role type
Manager, Regulatory Affairs (Oncology)
Builds
Regulatory submissions and strategies for oncology products in Japan
Domain
Life Sciences / Oncology / Japan Regulatory Market
Deliverable
client delivery
Required skills
Regulatory document preparation, PMDA/MHLW interaction, cross-functional collaboration, regulatory strategy development, compliance monitoring, SOP development
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare and submit regulatory documents (NDAs, PMDA consultations, Clinical Trial Notifications, package inserts); Collaborate with Clinical Development, Project Management, and Commercial teams; Lead regulatory strategies for global and local requirements; Interact with PMDA/MHLW to resolve issues; Monitor and interpret regulatory changes; Support development of regulatory SOPs
Seniority
Manager, hands-on IC