Regulatory Affairs Manager at Sanofi

Responsibilities

• Lead all country regulatory affairs activities across the company by establishing and maintaining effective working relationships with Sanofi, ensuring the implementation of regulatory strategies and projects to obtain marketing authorization for new products and approval of pertinent life cycle management initiatives, having as ultimate goal regulatory compliant products to be commercialized according to business strategy.
• Ensures optimal support to key stakeholders to ensure on-time delivery of high-quality dossiers in compliance with Health Authority requirements.
• Ensures optimal expertise on all dossier formats, structure, navigation, and life cycle management globally.
• Ensures close collaboration with the Quality and Process Improvement team to ensure optimal processes and tools are developed and implemented.
• Acts as the primary point of contact for the Regulatory Health Agency of the countries under his responsibility and assures regulatory environment is well understood and considered in country business strategies.
• Directs and develops the Regulatory teams.