Associate or Manager, PHAD Japan
Core
Act as a CMC development specialist and SME to support global/local CMC teams and TRD submission teams from clinical trials through NDA filings in Japan.
Role type
Associate or Manager, CMC Development Specialist (Pharmaceuticals)
Builds
Supports drug substance, drug product, formulation, process development, and control strategies for Japan filings.
Domain
Pharmaceuticals / CMC Development / Regulatory Affairs (Japan)
Required skills
CMC expertise (drug substance/product/formulation/process/control strategy/analytical science), Japanese pharmaceutical regulations knowledge, Japanese (native), English (reading/writing)
Preferred skills
5+ years pharma industry experience, English (business speaking/listening)
Technologies
None explicitly listed as tools/frameworks
Responsibilities
Provide scientific/technical insights on CMC risks for novel/complex elements; Develop expertise in new modalities and provide expert consultation; Review and prepare documents for Japan filings (J-NDA Module 3, J-QOS); Maintain global/local SOPs and perform QC activities for IMP release in Japan; Mentor associates and lead activities (Manager level only)
Seniority
Associate (Individual Contributor) or Manager (Strategy & Mentorship)