Associate or Manager, PHAD Japan
Listed on 2026-02-07
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Science
Research Scientist, Clinical Research
Job Description Summary
As a CMC development specialist, enhance Japan’s CMC development strategy by offering scientific and technical support to global/local CMC development teams and other departments, while keeping up with the latest technological advancements.
Major Accountabilities- Understand the CMC development strategy for assigned projects and provide insights on potential risks to be addressed and/or support the team’s understanding, especially regarding novel and complex scientific/technical elements.
- Research and acquire proficiency in topics related to modalities (small molecules including nucleic acids and radioligands, biologics, cell & gene, etc.) and technologies (formulations, process development, manufacturing and control strategy, etc.), and offer expert consultation.
- Input Japanese requirements/expectations in analytical field, seek solutions to challenges through scientific and technical discussions with local and global stakeholders, and review/prepare documents, protocols/reports required for Japan (e.g., specifications & test methods, analytical method validations, stability studies, compatibility studies, and technical experiments required for Japan filings and/or launches).
- Review J-NDA documents such as Module 3 and J-QOS.
- Learn scientific and technical knowledge for new analytical/manufacturing technologies, new modalities, and new regulations, and share what you learn with TRD members to improve TRD organizational knowledge and capabilities.
- Contribute to data generation (e.g., stability in special conditions, compatibility studies) of marketed products with global stakeholders to support market expectations.
- Provide technical information requested by commercial-related divisions.
- Collaborate with clinical stakeholders to accelerate clinical development in Japan from a CMC point of view.
- Support other requests from functions beyond TRD.
- Review and input Japan needs into global development-related SOPs and development manuals.
- Prepare and maintain Japan local SOPs and development manuals.
- Conduct release procedures and retain sample management according to SOPs and other related regulations.
- Ensure adequate reporting of adverse events, technical complaints, and compliance issues in accordance with company procedures.
- Ensure 100% timely delivery of all training requirements.
- Mentor/train associates to become competent players in PHAD Japan.
- Lead various activities in PHAD Japan.
Education: University or graduate (master s) degree (or higher) in pharmacy, science, engineering, or other technical fields.
Experience/Professional requirement:
• At least one CMC expertise such as drug substance, drug product, formulation development, process development, setting control strategy, analytical science, etc.
• Basic knowledge of Japanese Pharmaceutical regulations.
• Preferably 5+ years’ experience in the pharmaceutical industry.
* You do not need to be familiar with all the modalities or technical area mentioned in the Major Accountabilities section. If you have specialized skills in any CMC area and a strong motivation to learn about other technical field, we encourage you to apply.
Language skill:
• Native-level proficiency in Japanese is required, proficiency in reading and writing in English is necessary, and intermediate business-level speaking and listening skills in English are preferred.
* If the candidate possesses exceptional CMC skills, the English language requirements mentioned above can be flexible and open to discussion.
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