Manager, Regulatory Affairs, Specialty Care/GenMed
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
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