Global Regulatory Affairs Clinical Trials Coordinator

Job description

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.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for a candidate for a VIE mission of:

Global Regulatory Affairs Clinical Trials Coordinator - VIE Contract (W/M)

Target start date: 1/05/2024

Responsibilities:

·  Be expert in Clinical Trial Regulations
·  Provide support and regulatory expertise to Sanofi key stakeholders
·  Set up processes and coordinate Clinical Trial Applications (CTA) preparation at corporate level in close connection with Clinical Trials team members - especially regulatory (R&D Regulatory Affairs, Regulatory CMC, Regulatory Operations), and also Clinical study director, Clinical Trial Operational Manager, Global Pharmacovigilance, etc.
·  Follow-up of release, submission, and approval of CTA packages, identify any issues and propose resolution
·  Contribute to implementation and development of new processes associated to regulations (eg. New Clinical Trial Regulation in Europe, EU Clinical Data Disclosure)

Requirements:

·  Pharmacist / Scientist or other degree First experience in Regulatory Affairs or orther relevant experience
·  Good communication skills & negociation skills
·  Ability to solve issue & pro-active behavior  
·  Ability to work with multi-function teams
·  Ability to manage multi projects
·  Fluent English is a must

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.