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 CSLs 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 CSLs 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 CSLs 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 CSLs 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 companys 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 masterss 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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at 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 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 Experience:

Director