CSL Japan is looking at growing the Global Regulatory Affairs CMC team.
We are looking for a Senior Manager and 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
Senior Manager 8-10yrs and Manager over 5 years 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
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 technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
CSL North Sydney, New South Wales, AUS Office
5/32 Walker St, North Sydney, NSW, Australia, 2060
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