Jobs / China / Sanofi US Services INC
R&D - GRA - Regulatory Policy & Intelligence Lead - BJ
Sanofi US Services INC · 🌍 Beijing
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About the role
Provide strategic leadership and oversight for regulatory policy intelligence and moniting system, ensuring proactice assessment of regulatory landscape impacts and driving continuous improvement initiatives. • Establish, standardize, and implement comprehensive regulatory policies, evaluating their relevance and impact on internal processes, drug development, and corporate strategies through cross-functional collaboration. • Lead regulatory policy assessment and strategic positioning, working collaboratively with internal stakeholders to develop evidence-based recommendations and and translate external insights into tangible business impact. • Drive annual policy shaping priorities and coordinate the development of external advocacy positions, creating and executing strategic influence campaigns to achieve regulatory policy objectives. • Serves as a policy influencer to shape the external policy environment to advance Sanofi's regulatory and business objectives. ORGANIZATIONAL CONTEXT: (See Organizational chart attached) SUPERVISED RESOURCES: 0 KEY ACCOUNTABILITIES: • Strategic Leadership & System Development • Lead establishment and continuous improvement of regulatory monitoring and intelligence mechanisms • Design and implement standardized processes for policy impact assessment and strategic response • Provide senior-level representation in cross-functional policy governance forums and lead strategic regulatory initiatives across technical and operational excellence teams • Drive cross-functional collaboration to ensure effective integration of regulatory intelligence into business operations. • Policy Analysis & Strategic Assessment • Provide executive-level analysis of critical regulatory developments with strategic recommendations. • Lead regulatory policy commenting and assessment processes across the RA team • Coordinate timely and efficient assessment assignments to ensure comprehensive coverage. • Communication & Knowledge • Develop and disseminate monthly/quarterly regulatory intelligence summaries and executive briefings • Edit and coordinate regulatory newsletters and communications to senior leadership • Facilitate knowledge sharing and best practice dissemination across functions • External Engagement & Industry Leadership • Serve as primary liaison with global RSP groups, contributing expertise on regional policy analysis (ICH, RWE, AI, Clinical Deversity etc.) • Establish and maintain strategic partnerships with key industry associations (RDPAC, etc.) • Strategic Advocacy & Position Development • Lead annual policy shaping priority planning and strategic advocacy initiatives. • Coordinate development of regulatory position papers and external advocacy strtegies • Coordinate stakeholder engagement with international organizations (Epifia, PhRMA etc.) for policy influence • Act consistently with Sanofi best practices and code of ethics • undefined JOB-HOLDER ENTRY REQUIREMENTS: Education: • Master degree or above in Life Science, Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases) • undefined Experience & knowledge： • 10+ years’ RA or RI experience and industry experience. • Extensive and proven expertise in Regulatory environment in healthcare is plus. • Minimum 5+ years in senior leadership roles with demonstrated team management and strategic planning capabilities. • Proven track record in regulatory policy development, advocacy, or government relations. • Experience with international regulatory frameworks and cross-regional policy coordination. • Background in trade associations or policy influence organizations highly valued. Core competencies： • Strategic Competencies • Advanced strategic thinkin