Regulatory Affairs Analyst

Responsibilities

• Support the management of sanitary registrations, renewals, and regulatory modifications for assigned products to ensure compliance with local requirements.
• Prepare, collect, and review necessary documentation for regulatory submissions, ensuring data quality and integrity.
• Follow up on regulatory procedures with local health authorities, monitoring application progress and supporting the resolution of requirements.
• Collaborate with cross-functional teams to obtain timely regulatory approvals and meet business objectives.
• Review and manage promotional materials and other related documents to ensure alignment with current regulations.
• Maintain updated documentation, databases, and regulatory systems to ensure information availability.

Requirements

• At least 1 year of experience working with regulatory affairs teams.
• Degree in Pharmaceutical Sciences, Chemistry, Biopharmaceuticals, or a related field.
• Knowledge of GxP regulations and local pharmaceutical legislation.
• Proficiency in Veeva Vault or similar regulatory document management platforms.
• Intermediate-advanced English language skills (verbal and written).
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, and Outlook).
• Ability to work collaboratively in multicultural and global environments.

Preferred Qualifications

• Familiarity with Artificial Intelligence (AI) tools for task optimization and information analysis.
• Strong attention to detail and ability to manage multiple priorities effectively.

About the Company

Sanofi is a biopharmaceutical company driven by R&D and powered by AI, committed to improving lives and delivering compelling growth. We leverage a deep understanding of the immune system and an innovative pipeline to invent medicines and vaccines that protect millions of people around the world.