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Head of Quality Regulatory

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Sanofi

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Location:
Mexico , Toluca

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Quality Regulatory department serves as the strategic bridge between regulatory compliance and operational excellence across our manufacturing sites. Our mission is to ensure all commercialized products meet the highest regulatory standards while enabling business growth through proactive regulatory strategy. We lead regulatory lifecycle management, drive continuous improvement in quality systems, and foster a culture of compliance excellence. What makes our team unique is our ability to balance strategic regulatory intelligence with hands-on operational support, ensuring seamless product launches and sustained market presence globally.

Job Responsibility:

  • Lead regulatory compliance strategy ensuring alignment between approved registrations and site operations
  • Drive market authorization activities worldwide, including territory extensions, transfers, and post-license commitments
  • Oversee batch release processes and ensure timely product submissions and approvals
  • Lead preparation and execution of global quality audits and regulatory inspections
  • Manage internal and supplier audit programs from planning through follow-up
  • Direct change control assessments and define regulatory strategies with cross-functional teams
  • Oversee CMC documentation and dossier preparation for regulatory submissions
  • Lead semi-annual quality performance reviews and site quality planning
  • Drive implementation of quality maturity frameworks and continuous improvement initiatives
  • Build and develop a high-performing Quality Regulatory team

Requirements:

  • Proven track record in pharmaceutical regulatory affairs and quality management with demonstrated leadership in managing complex regulatory compliance programs
  • Strategic thinking, executive presence, strong leadership and team development capabilities, excellent stakeholder management, decision-making under pressure, change management expertise
  • Deep expertise in regulatory affairs, quality systems, chemistry manufacturing and controls documentation, global regulatory submissions, audit management, and pharmaceutical regulations across multiple markets
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific field
  • advanced degree preferred
  • Fluency in both Spanish and English is mandatory

Additional Information:

Job Posted:
February 17, 2026

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