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Manager, Regulatory Affairs, Specialty Care/GenMed

Synthorx

Synthorx

Legal
Tokyo, Japan
Posted on Tuesday, November 7, 2023

Roles & Responsibilities

The R&D Regulatory Affairs has responsibility for managing products under development and/or marketed products with new indications/dosages.

· Develop 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,

· Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and arrange the internal review of J-CTD,

· Define, Coordinate and contribute to the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA Consultation Meetings) and major regulatory submission (e.g. J-NDA and J-sNDA) and/or any type of responses document to Health Authority questions with the stakeholders (Non clinical, clinical, Medical, Pharmacovigilance, etc.),

· Ensure maintenance and compliance of regulatory activities for development and marketed products,

· Be a communication hub between Australia/South Korea and Global as the JPAC representative,

· Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.

· Coordinate Japanese Package Insert Revision activities on Commercial and Medical Division’s request that is covered by PMDA New Drug Review Division.

Knowledge And Skills:
Leadership skill with Play to win behaviors

· Strategy focus and clear/courageous mindset

· Mutual respect by the open communication and well-stakeholder management

· Knowledge /experience of regulatory submission and approval.

· Experience of people leader (including coaching/mentoring) and great passion for the people development

· Respect others with DE&I mindset

English communication skill

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.