Regulatory Continuous Improvement Performance (CIP) – Audit & Inspection Readiness Coordinator - VIE Contract

Regulatory Continuous Improvement Performance (CIP) – Audit & Inspection Readiness Coordinator - VIE Contract

• Location: Hungary, Budapest
• Target start date: 01/04/2026

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

As Regulatory Continuous Improvement Performance (CIP) – Audit & Inspection Readiness Coordinator VIE within our Regulatory team, you will join the Regulatory Compliance & Performance Office team part of the Global Regulatory Affairs (GRA), working on three key areas: audit & inspection readiness, quality management of the service providers and business quality representative (BQR) for computerized systems project.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Ready to get started?

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Act as key contact point with internal Quality organizations to prepare and ensure follow-up of audits and inspections.
• Coordinate and provide direct support to regulatory departments audited/inspected in all phases of audit and inspection process through preparatory and supporting activities.
• Liaise with concerned regulatory departments to elaborate relevant Corrective Actions and Preventive Actions (CAPAs).
• Assure monitoring of CAPAs and organize CAPA Effectiveness Review when appropriate.
• Participate in development of trend analysis on audit and inspection results.
• Provide initial training on audit and inspection readiness for Subject Matter Experts (SMEs) who have no prior experience on this topic.
• Lead best practices sharing and lessons learned following audits and inspections. Manage communication roadmap for audit & inspection readiness.
• Conduct Quality Risk Assessments (QRAs). Maintain quality management tool for Service provider up-to date.
• Support the role of the Business Quality Representative (BQR) in computerized systems projects.

About you

Experience:

• Regulatory Affairs and/or Quality experience is a plus.
• Knowledge of Microsoft Office and Windows tools (Outlook, Word, Excel, PowerPoint, Teams); experience with Power BI is a plus.

Soft and Technical skills:

• Clear and effective communication, both written and spoken.
• Team collaboration and cross-functional working abilities in an international environment.
• Demonstrated capacity to learn quickly and apply new knowledge effectively.
• Proactive and problem-solving attitude.
• Organizational skills, able to manage multiple tasks and deadlines.
• Strong attention to detail and accuracy.
• Continuous Improvement Mindset.

Education:

• Master's degree in Life Sciences, Engineering (Chemical, Biomedical, Industrial), Pharmacy, Chemistry, Biology, or other related scientific/technical fields.

Languages:

• Fluent English (written and verbal).

Why choose us?

• Be part of a pioneering biopharma company where patient insights shape drug development.
• Work at the forefront of AI-powered science that accelerates discovery and improves outcomes.
• Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. 
• Help improve the lives of millions of people globally by making drug development quicker and more effective. 
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
• Achieve genuine work-life balance in a supportive R&D environment.