Job description
The Japan Regulatory Affairs Lead (CMC-focused) holds dual accountability as a CMC subject matter expert and as a team leader, responsible for building and leading a cross-functional regulatory team to oversee and deliver multiple regulatory services projects in Japan. Primary Responsibilities: Act as the primary CMC expert, defining and finalizing CMC and GMP regulatory strategies for assigned products and portfolios in line with Japanese regulations, guidance, and client procedures.
Mentor and enable FTEs to execute tasks independently. Lead change control assessments, develop submission strategies, and identify applicable Japan regulatory requirements. Plan and execute regulatory strategies and activities based on manufacturing-initiated change controls, considering product supply, quality assurance, and commercial impact.
Ensure all submissions fully comply with Japanese regulatory requirements. Serve as the primary liaison with health authorities (e.g., MHLW and PMDA), representing the company in negotiations, agency interactions, and the preparation and execution of regulatory meetings. Define and drive geographic expansion strategies for the client’s actively marketed product portfolio.
Serve as CMC Product Lead for assigned products, with end-to-end accountability for regulatory milestone delivery across the product lifecycle. Support GMP inspections (PAI for NDA, PCA/Periodic) by providing manufacturing site information listed in marketing authorization applications and assisting the lead inspection teams.
Lead Foreign Manufacturer Accreditation activities, including facility registration planning and preparation of PMDA consultation packages. Execute regulatory strategies by leading the development, review, and approval of CMC submission content for post-approval changes and health authority responses, in accordance with established processes and systems.
Provide regulatory leadership for product in-licensing, due diligence, divestments, and product withdrawals. Partner closely with clients and external stakeholders to ensure compliant change management and maintain strict adherence to regulatory standards. Demonstrate deep expertise in J-NDA/J-ANDA processes (dossier development through approval), post-marketing maintenance and re-examinations, JAN applications, expedited pathways, and other Japan-specific submissions to ensure timely approvals and uninterrupted product supply.
Apply advanced knowledge to guide and lead teams in preparing application documents (Application Forms and CTDs), managing GMP/GCTP inspections (domestic and overseas), Foreign Manufacturer Accreditation, Master File coordination, Japanese Pharmacopoeia applicability, pharmaceutical development, and manufacturing and quality controls (GMP, GCTP, GQP).
Proactively identify, assess, and communicate regulatory risks, recommend mitigation strategies, and escalate issues to management as appropriate while ensuring lifecycle milestone delivery.