Director, Global Regulatory Affairs CMC Japan

The Team Lead, Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team.

Reporting to the Head of Global Regulatory Affairs CMC you will partner closely with Global Regulatory Affairs CMC, Japan Regulatory Affairs, Global Regulatory Affairs and Safety, R&D, Manufacturing, Technical Operations, and Quality

stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio.

Define Japan-relevant regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s product portfolio and represent CSL in official regulatory CMC capacities, acting as responsible person in interactions with regulatory agencies, specifically PMDA and MHLW.

Your main responsibilities & accountabilities

• Provide proactive leadership and strategic direction to the assigned Global Regulatory Affairs CMC – Japan team. This includes defining and optimizing regulatory strategies, objectives, and policies that govern and support the development, registration, commercialization, and life-cycle management of CSL’s Japan product portfolio

• Mentor, develop, and coach a high-performing regulatory affairs team. Foster talent, build team capabilities, and create a culture of continuous learning and professional growth. Provide clear direction, constructive feedback, and career development support within a dynamic work environment

• Lead the Japan regulatory CMC strategy for the development and commercial product portfolio, collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC, Regulatory Affairs Japan, Global Regulatory Affairs and Safety, R&D, Global Operations, and Japan-based business functions

• Oversee the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including new marketing applications, clinical trial applications, variations/supplements, periodic compliance reports and renewals. Ensure timely execution aligned with regulatory expectations and business goals

• Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system. This includes the Japan-specific reporting category and detailed submission documentation requirements

• Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL’s competitive positioning for its product portfolio

• Represent CSL in official regulatory CMC capacities, acting as responsible person in interactions with regulatory agencies. Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests. Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management

• Lead the development of strategic and tactical plans for Global Regulatory Affairs CMC, advising Global Regulatory Affairs CMC leadership and CSL stakeholders on regulatory requirements and their implications for project timelines, compliance, and business strategy. Contribute to the evaluation of new business opportunities in collaboration with development teams

• Provide regulatory consultation to internal CSL functions, including Global Operation functions, R&D, and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence

• Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations

• Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards

• Ensure regulatory policies and procedures are developed and implemented in accordance with applicable international standards and requirements

• Support the creation and execution of regulatory policies, processes, and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness across Global Operations and its stakeholder network

• Support the outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements

Your Qualifications, Skills & Experience

• A masters’s degree in biological, chemical, or life science, or a related field is required; an advanced degree (e.g., PhD) is preferred

• 10 years of progressive experience in regulatory roles within the biopharmaceutical or plasma industry, demonstrating increasing levels of responsibility and leadership.

• 5 years of managing and developing a team of regulatory professionals, ensuring alignment with organizational goals and fostering a high-performance culture.

• Strong technical foundation with in-depth knowledge of Japanese drug regulations and international standards governing drug product development, manufacture, registrations, and life-cycle management. Comprehensive knowledge of global regualtory CMC requirements.

• Fluency in Japanese and English (spoken, written, and comprehension)

• Proven expertise in authoring, reviewing, and managing regulatory submissions at both federal and state levels, ensuring accuracy, compliance, and timely delivery.

• Demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders

• Skilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering a culture of accountability and excellence

• Exceptional oral and written communication skills, with a strong ability to negotiate, influence, and represent regulatory positions effectively

• Committed to the highest standards of compliance, integrity, and adaptability, 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.