Job Description
Job Title:
Senior Regulatory Affairs – CMC Specialist
Department:
Regulatory Affairs
Location: Tokyo
Japan
Reports to:
Head of Regulatory Affairs, Japan
Employment Type:
Permanent or Contract (Flexible)
Compensation:
Competitive, commensurate with experience and seniority
Position Summary
The Senior Regulatory Affairs – CMC Specialist will be responsible for leading and supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to product development, registration, and lifecycle management for the Japanese market.
This role combines strategic regulatory insight with technical expertise in analytical sciences and manufacturing. The successful candidate will contribute to CMC dossier preparation, regulatory strategy development, and interactions with Japanese regulatory authorities.
Key Responsibilities
- Author, review, and manage CMC sections of regulatory submissions (e.g. J-NDA, partial change, minor change, and post-approval variations).
- Evaluate analytical method validation, specification setting, and stability data to ensure scientific soundness and compliance with regulatory expectations.
- Develop and execute Japan-specific CMC regulatory strategies aligned with PMDA guidance, ICH guidelines, and global regulatory standards.
- Collaborate closely with internal CMC, Quality, and Regulatory teams to ensure submission accuracy and consistency across global filings.
- Support and coordinate CMC-related discussions and responses during PMDA consultations and reviews.
- Contribute to analytical method transfer, stability studies, and GMP inspection readiness as required.
- Maintain an up-to-date understanding of evolving Japanese regulatory requirements (GQP, GMP, validation standards).
- Ensure timely submission and documentation of CMC deliverables across development and lifecycle phases.
- Support the preparation and review of Quality Overall Summaries (QOS) and maintain clear records of submissions and regulatory communications.
Qualifications And Experience
- Bachelor's degree (or higher) in Pharmaceutical Sciences, Analytical Chemistry, Pharmacy, or a related discipline.
- Minimum of 5 years' Regulatory Affairs experience, with at least 2 years focused on Japan CMC submissions.
- Strong scientific understanding of analytical methods, formulation, and manufacturing processes.
- Practical laboratory experience in QC, R&D, or analytical development (e.g. HPLC, GC, dissolution).
- Experience with biologics, biosimilars, or sterile injectable products is preferred.
- Familiarity with PMDA expectations for analytical validation, specification setting, and stability justification.
- Experience collaborating with Contract Manufacturing Organizations (CMOs) or Marketing Authorization Holders (MAHs) in Japan.
- Excellent communication skills in English (Japanese language ability desirable).
- High attention to detail and strong project management skills.
- Ability to manage multiple priorities in a fast-paced, cross-functional environment.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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