Regulatory Strategy Specialist

As a Regulatory Strategy Specialist, you will play a critical role in advancing CSL's product portfolio in Japan.

Reporting to the Head of Regulatory Affairs Japan you will develop and execute regulatory strategies for new product registrations and lifecycle management activities, working closely with internal stakeholders and regulatory authorities to ensure timely approvals and uninterrupted product supply. As a key representative of CSL, you will lead regulatory interactions, coordinate submissions, and provide strategic guidance to support the successful delivery of innovative therapies to patients.

Main Responsibilities

• Develop and execute Japan regulatory strategies for assigned development products, ensuring Japan-specific requirements are appropriately reflected in global development plans.
• Lead and support PMDA interactions, including regulatory consultations, preparation of briefing materials, and responses to health authority questions.
• Prepare, coordinate, and review key regulatory submissions, including Clinical Trial Notifications (CTNs), CTD documents, New Drug Applications (NDAs), and other relevant applications.
• Evaluate and pursue appropriate regulatory pathways and designations, including Orphan Drug Designation and other applicable programs.
• Collaborate closely with global and Japan cross-functional teams, providing regulatory perspectives, identifying risks and opportunities, and contributing to development decisions from clinical development through approval.

Qualifications, Skills & Experience

• Bachelor’s degree or higher in pharmacy, pharmaceutical sciences, medicine, biological sciences, chemistry, or another relevant life-science discipline.
• At least 10 years of experience in pharmaceutical or biotechnology drug development, with a solid understanding of the overall drug development process.
• Substantial experience in one or more drug development functions, such as Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, Nonclinical Development, or other closely related areas.
• Good understanding of clinical development, including clinical development plans, clinical trials, data interpretation, and the process from development through marketing authorization.
• Ability to understand scientific and clinical information and translate complex issues into practical development strategies, options, and recommendations.
• Experience working effectively in cross-functional project teams.
• Business-level English communication skills, sufficient to participate in global meetings, understand and review English-language documents, and communicate effectively with global colleagues.
• Professional or native-level Japanese communication skills.
• Strong problem-solving, project-management, and prioritization capabilities.
• A positive, proactive, and solution-oriented mindset, with the willingness to take on new challenges and learn areas outside the candidate’s previous functional experience.
• Strong interpersonal skills and the ability to build effective working relationships in a cross-functional and global matrix environment.

Preferred Qualifications

• Experience in Regulatory Affairs is preferred but not required.
• Experience with Japanese drug development and/or interaction with PMDA.
• Experience supporting PMDA consultations, Clinical Trial Notifications, regulatory submissions, CTD preparation, or responses to health authority questions.
• Experience contributing to Japan development or regulatory strategy within a global development program.
• Experience communicating Japan-specific development or regulatory requirements to global project teams.
• Experience with global drug development programs and multicultural project teams.
• Experience in therapeutic areas or modalities relevant to the company’s development portfolio.
• Advanced scientific or medical degree, such as MSc, PhD, PharmD, or MD, is preferred