Role & Responsibilities

This position is heading the RA Specialty Care/GenMed group, which is critical for the sanofi business.

Head of Regulatory Affairs, Specialty Care/GenMed is responsible for leading the team and encouraging changes and challenges, influencing stakeholders inside and outside the company, contributing to the achievement of organizational goals, enhancing performance and productivity, and fostering talent development.

Take the lead of developing the best Specialty Care/GenMed regulatory strategy for new drug developments, Health Authority meetings and Japan New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for products under development and/or marketed products (scope: new drug application, partial change application for new indication and/or new dosage and administration with clinical trial, new formulation regardless of clinical trial).

Ensure maintenance and compliance of regulatory activities for development and marketed products.

Build relationship of trust with regulatory authority by enhancing the partnership.

Lead the cross-functional activities at company level /GRA.

Responsible for people management and development and culture shift toward “Take the lead” behaviors, especially patients focus and stretch mind set.

Knowledge, Skills & Competencies / Language

• Knowledge of new drug development and regulatory review for the approval.
• People development skill.
• Negotiation skills.
• Communication skills.
• Able to make continuous efforts with a focus on results.
• A person who can work positively on his/her own.
• A person who can cooperate effectively with others.
• Native level of Japanese, TOEIC 800 score or above in English.
• Required English skills such as the ability to accurately understand and use technical terms related to drug development and regulations, create the specialized regulatory documents, advanced listening and speaking skills to effectively communicate in international meetings, expressing opinions, negotiations and discussions with Global stakeholders about the complicated issues, reading comprehension to efficiently read and understand English professional documents.

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Qualifications

• Knowledge of regulatory. CMC, non-clinical, clinical development, or CTD.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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