Manager, RA CMC Group, Regulatory Affairs
Core
Execute regulatory affairs activities for assigned projects in Japan, ensuring timely submission of documents to PMDA/MHLW and supporting regulatory strategy.
Role type
Manager, Regulatory Affairs (CMC Group)
Builds
Regulatory submissions (NDAs, GMP Applications, Licensing Applications) for pharmaceutical products in Japan
Domain
Pharmaceutical / Healthcare / Regulatory Affairs
Deliverable
client delivery
Required skills
Japan regulatory knowledge, CMC regulatory strategy, regulatory document preparation, cross-functional collaboration, regulatory change monitoring, SOP development
Preferred skills
New drug development project experience, managing communications with regulatory authorities
Technologies
None stated
Responsibilities
Prepare and submit regulatory documents to PMDA/MHLW; Collaborate with cross-functional teams on product life-cycle management; Lead CMC regulatory strategies; Interact with local authorities to resolve issues; Monitor and interpret regulatory changes; Support development of regulatory SOPs
Seniority
Manager, hands-on IC