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
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.
