Director, Global Regulatory Affairs CMC Japan

CSL•Ottawa, ON

About The Position

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.

Requirements

A masters’s degree in biological, chemical, or life science, or a related field is required
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.

Nice To Haves

an advanced degree (e.g., PhD) is preferred

Responsibilities

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