Main responsibilities:

Support the execution of Regulatory Strategy. Implement the regulatory strategy for assigned products by processing registrations, renewals, post-approval changes, and promotional materials to obtain required health authorizations for business units.

• Ensure Complete Regulatory Submissions. Guarantee submission of complete dossiers to local health authorities through effective preparation and review processes to obtain timely approvals.

• Maintain Global Data Systems. Register product-related information in global electronic systems (Veeva Vault RIM, Qualipso, 4M PromoMats, OnePack) to comply with Sanofi's global guidelines.

• Manage Documentation and Archives. Compile physical and electronic product dossier files by creating comprehensive backup documentation of all submissions to health authorities, ensuring compliance with corporate and regulatory requirements.

• Manage Stakeholder Communications. Effectively communicate area requirements to internal and external clients (translators, notaries, vendors, and service providers) to obtain corresponding results and deliverables.

• Regulatory Intelligence Support: Update Country Cards and STARR database for new registrations and modifications.

• Foster Cross-Functional Collaboration. Build effective collaborative networks with business partners (Quality, Pharmacovigilance, Medical, Institutional and Private Marketing, Supply Chain, Market Access, and Public Affairs) to ensure business continuity and objective achievement.

• Continuous Improvement: Contribute to the development of standard operating procedures (SOPs) related to regulatory affairs.

About you

Experience: Entry Position

Languages: Advanced English

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