# Global Regulatory Affairs CMC: Senior Manager - Japan at CSL

CSL is hiring a Global Regulatory Affairs CMC: Senior Manager - Japan in Tokyo, Japan. Level rates it Little AI ●○○○; you can [apply on CSL](https://jobsbylevel.com/go/93c7eaa1-7804-4468-b864-200a973827f8?utm_medium=ai-agent).

AI Level 1, AI centrality 39 out of 100. APAC, JP, Tokyo, CSL Behring.

## Details

- Company: [CSL](https://jobsbylevel.com/companies/csl)
- AI level: AI Level 1 (score 39 out of 100)
- Location: APAC, JP, Tokyo, CSL Behring
- Posted: October 6, 2026
- Apply: https://jobsbylevel.com/go/93c7eaa1-7804-4468-b864-200a973827f8?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=global-regulatory-affairs-cmc-senior-manager-japan-at-csl-a60c1b

## Description

CSL Japan is looking at growing the Global Regulatory Affairs CMC team. We are looking for a Senior Manager where you will shape CSL's regulatory CMC strategy in Japan, partnering across Global Regulatory Affairs, R&D, Manufacturing and local business teams to support the development, registration, commercialisation and lifecycle management of our product portfolio. Reporting to the Director, Team Lead, Global Regulatory Affairs CMC - Japan, you will provide strategic guidance, influence key health authority interactions, and help bring innovative therapies to patients. Your Responsibilities Lead and execute Japan regulatory CMC strategies across CSL's development and commercial product portfolio, ensuring alignment with global business and regulatory objectives. Manage the preparation, review and submission of high-quality CMC regulatory filings in Japan, including NDAs, variations, renewals, clinical trial applications and health authority responses. Serve as the subject matter expert for Japan CMC regulatory requirements, providing strategic guidance on regulatory pathways, compliance obligations and evolving regulatory expectations. Represent CSL in interactions with Japanese health authorities, including PMDA and MHLW, leading regulatory discussions, negotiations and submission activities. Partner with cross-functional global and local stakeholders to drive regulatory strategy, support change management activities, and ensure compliant product development and lifecycle management. Provide regulatory leadership on business-critical issues, identifying risks, proposing solutions and supporting informed decision-making. Contribute to the continuous improvement of regulatory processes, systems and governance while ensuring accurate maintenance of regulatory records and commitments. Mentor and support matrix team members and regulatory colleagues to strengthen capability, collaboration and execution excellence. Your Qualifications, Skills & Experience A bachelor’s degree in biological, chemical, or life science, pharmacy, or a related field is required; an advanced degree (e.g., MS, PhD) is preferred 8-10yrs and Manager of progressive experience in regulatory CMC roles within the biopharmaceutical or plasma industry, demonstrating increasing levels of responsibility Demonstrated experience supporting Japanese regulatory activities including NDA, PCA, MCN, health authority interactions, regulatory submission management, and responses to health authority questions Experience supporting development, registration, and lifecycle management activities for biologic and/or plasma-derived products is strongly preferred. Strong technical foundation with in-depth knowledge of Japanese drug regulations and international standards governing drug product development, manufacture, registrations, and lifecycle management. Strong knowledge of global regulatory CMC requirements Fluency in Japanese and English (spoken, written, and comprehension) Proven expertise in authoring, reviewing, and managing regulatory submissions, ensuring accuracy, compliance, and timely delivery Demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders Good analytical skills and sound judgment in assessing regulatory risks and developing risk-based regulatory approaches Exceptional oral and written communication, presentation, and negotiation skills, with a strong ability to influence and represent regulatory positions effectively Committed to the highest standards of compliance, integrity, adaptability, and teamwork, with a strong focus on aligning regulatory strategy with evolving business needs Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve goals bal Regulatory Affairs CMC: Senior Manager & Manager - Japan About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/global-regulatory-affairs-cmc-senior-manager-japan-at-csl-a60c1b

Source: https://jobsbylevel.com/jobs/global-regulatory-affairs-cmc-senior-manager-japan-at-csl-a60c1b

## Cite this page

Level. https://jobsbylevel.com/jobs/global-regulatory-affairs-cmc-senior-manager-japan-at-csl-a60c1b.

Get job alerts: https://jobsbylevel.com/newsletter