International Regulatory Strategist

Sanofi

Main responsibilities:

• Drive early engagement with international markets countries through proactive knowledge sharing on clinical development programs and key project milestones, ensuring local teams are ready to partner in local launch readiness and excellence discussions
• Build robust scenario and comprehensive regulatory strategies tailored to regional requirements and market-specific considerations while standardizing dossier preparation by leveraging the global dossier as the foundation
• Partner with countries demonstrating commercial interest to develop ready-to-deploy strategies that can be executed upon business case approval
• Act as the first line of response to health authorities questions for international regional markets, leading the draft of responses with collaboration of subject matter experts
• Maintain deep understanding of international regulatory landscapes and emerging changes, translate complex regulatory updates into actionable insights, and assess their potential impact on global regulatory strategies
• Serve as regional regulatory lead and point of contact with local affiliates for pre-submission meetings with Health Authorities on projects/products in their remit, and may lead international country Health Authority meetings and preparations as designated
• Leverage regulatory expertise to lead the definition of international regulatory strategy, enabling and driving execution of aligned regulatory strategy for assigned projects as a key member of the Global Regulatory Team
• Contribute to development of harmonized, One Sanofi regulatory voice through participation in appropriate committees and forums at the direction of the Global Regulatory Lead
• Actively contribute to Global Regulatory Meetings and ensure respective regulatory team members have information necessary to contribute to development and execution of Global Regulatory Strategy
• Proactively contribute to development of Global Regulatory Project Strategy (GRPS) and ensure alignment with core product labeling for products in development and life cycle management
• Liaise with clinical, commercial, and other internal business partners in partnership with the Global Regulatory Lead to enable successful regulatory outcomes in international regions
• Identify regulatory risks and propose mitigations in collaboration with the Global Regulatory Lead to cross-functional teams using Sanofi standardized methodologies
• Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning activities, including generating submission content plans, submission tracking, and document management