Global Regulatory Affairs Clinical Trials Coordinator

Global Regulatory Affairs Clinical Trials Coordinator

Sanofi

Berlin, Germany

About the job

As Global Regulatory Affairs Clinical Trials Coordinator VIE within our Global Regulatory Affairs team, you’ll manage regulatory activities related to Clinical Trials Applications, from planning and dossier preparation, then submission, responses to Health Authorities and approvals of Trials. We are developing our knowledge in Clinical Trial Applications (CTA) related Intelligence, in particular our knowledge in the European Clinical Trial Regulation. Your work will support knowledge development, and field experience for the European Clinical Trial Regulation processes.

Main responsibilities:

• Provide regulatory expertise to Sanofi key stakeholders and help teams understand and follow important healthcare regulations.
• Set up processes and coordinate the preparation of Clinical Trial Applications (CTAs).
• Work closely with different departments including R&D, Clinical Operations, and Pharmacovigilance teams.
• Ensure all documentation meets quality standards.
• Monitor the progress of CTAs through submission and approval stages.
• Identify potential issues early and develop practical solutions, keep projects moving forward on schedule and drive process improvement.
• Help implement new regulatory processes (eg. Clinical Trial Regulation in Europe, EU Clinical Data Disclosure).
• Contribute to developing more efficient ways of working, stay current with changing regulations and help teams adapt.

About you

Experience:

• Previous experience in pharmaceutical industry in Regulatory Affairs or similar field.
• Clinical Trial Regulations experience is highly preferred.

Soft and technical skills:

• Good communication & negotiation skills.
• Proactiveness, and problem-solving ability.
• Ability to work with cross-functional teams.
• Ability to handle multiple tasks and projects simultaneously.

Education:

• Master’s Degree in Pharmacy, or other relevant scientific field.

Languages:

• Fluency in English, German knowledge would only be an asset, but is not needed for the job.