Location: Japan
Employment Type: Full-time / Contract
Department: Regulatory Affairs – CMC
Experience: 10–15+ years
Languages: Japanese & English (mandatory)
We are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused). This role is responsible for defining and executing Japan-specific CMC regulatory strategies, ensuring compliance with Japanese regulations, and leading cross-functional regulatory teams across the product lifecycle.
Key ResponsibilitiesCMC & Regulatory Strategy- Act as the primary CMC Subject Matter Expert for Japan regulatory activities.
- Develop and execute CMC and GMP regulatory strategies in alignment with Japanese regulatory requirements.
- Lead change control evaluations, submission planning, and regulatory impact assessments.
- Ensure all submissions are prepared in full compliance with Japan regulations and guidance.
- Serve as the primary liaison with PMDA and MHLW.
- Lead preparation and participation in agency meetings and consultations.
- Support new drug registrations, post-approval changes, and lifecycle management activities.
- Lead preparation, review, and approval of CMC submission documentation (CTD, Application Forms).
- Manage J-NDA / J-ANDA submissions, post-marketing maintenance, and re-examination activities.
- Support GMP inspections (PAI, periodic) and Foreign Manufacturer Accreditation.
- Build and lead cross-functional regulatory teams (CMC, RA operations, labeling, clinical RA).
- Oversee multiple regulatory projects and ensure delivery of regulatory milestones.
- Provide regulatory leadership for in-licensing, divestment, and product withdrawal activities.
- 10–15+ years of experience in Japan Regulatory Affairs (Pharmaceuticals).
- Strong expertise in CMC, PMDA, MHLW, GMP, GQP, and GCTP.
- Proven experience with J-NDA / J-ANDA submissions.
- Experience in Foreign Manufacturer Accreditation and PMDA consultations.
- Strong leadership, communication, and stakeholder management skills.
- Fluent Japanese and English (written and verbal).
- Senior leadership position with end-to-end ownership of Japan regulatory strategy.
- High visibility role with global and regional stakeholders.
- Opportunity to lead complex and high-impact regulatory programs in Japan.
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Tokyo Digisailor Full time￥400,000 - ￥500,000 per yearWe are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused). This role is responsible for defining and executing Japan-specific CMC regulatory strategies, ensuring compliance with Japanese regulations, and leadin ...
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Tokyo DigisailorWe are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused) to define and execute Japan-specific CMC regulatory strategies. · 10–15+ years of experience in Japan Regulatory Affairs (Pharmaceuticals). · ...
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Tokyo Digisailor Full timeWe are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused) responsible for defining and executing Japan-specific CMC regulatory strategies ensuring compliance with Japanese regulations leading cross-functional r ...
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