Regulatory Affairs Manager – Sanofi

As a Regulatory Affairs Manager at Sanofi Japan, you will serve as the vital link between global research divisions and local regulatory bodies. Operating at the intersection of cutting-edge biopharmaceutical innovation and compliance frameworks, you will develop, refine, and execute robust regulatory CMC strategies customized entirely for the Japanese healthcare environment.

Key Responsibilities

1. Strategic CMC Leadership: Formulate innovative local regulatory CMC strategies and detailed risk assessments for development projects. Collaborate closely with Global Regulatory CMC&D functional partners to ensure local actions seamlessly integrate with overarching international targets.

2. Health Authority Interactions: Act as the primary point of contact and lead strategic interactions with Japanese Health Authorities, including the PMDA Japan. Manage briefing documents, facilitate consultations, and navigate complex negotiations to maintain an optimal Probability of Success (POS).

3. Lifecycle Management: Oversee and manage post-marketed CMC change controls for assigned product lines. Execute thorough regulatory impact assessments and implement local action plans in accordance with shifting commercial and medical needs.

4. Cross-Functional Collaboration: Partner with global and local manufacturing and supply (M&S) entities to assemble high-quality dossier packages, ensuring swift and technically accurate responses to regulatory inquiries.

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Qualifications

1. Industry Experience: A solid background in pharmaceutical R&D, quality control, or regulatory affairs with direct, hands-on exposure to CMC regulatory frameworks.

2. Technical Expertise: Proven experience handling PMDA consultations, quality-focused regulatory meetings, and Japanese CTD (J-CTD) preparation.

3. Soft Skills: Strong analytical mindset, superior negotiation capabilities, and the capacity to influence without formal authority across cross-functional, multi-matrixed global teams.

4. Language Proficiency: Native-level fluency or equivalent in Japanese is mandatory alongside business-level English proficiency (TOEIC 800+ or equivalent) to coordinate effectively with international stakeholders.