Job detail for R&D - GRA - Regulatory Policy & Intelligence Lead

Provide strategic leadership and oversight for regulatory policy intelligence and monitoring systems, ensuring proactive 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 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 :

• 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 Diversity 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 strategies

• 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 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.

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