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
JOB-HOLDER ENTRY REQUIREMENTS:
Education:
- Master degree or above in Life Science, Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases)
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 thinking and policy analysis capabilities
• Regulatory landscape assessment and trend identification
• Stakeholder management and external relationship building
• Leadership Competencies:
• Influential leadership and change management
• Cross-functional collaboration and matrix management
• Executive communication and presentation skills
• Technical Competencies:
• Regulatory intelligence systems and data analysis
• Policy development and advocacy strategy design
• Project management and process optimization
• English proficiency-business level
• Advanced proficiency in MS Office Suite and data visualization tools.
Pursue
progress, discover
extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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