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.

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: Submission Manager - VIE Contract (W/M)

Target start date: 01/09/2023

In the Operations department of Global Regulatory Affairs, the Submission Manager VIE plans and coordinates the preparation, publishing and submission of regulatory dossiers to European Health Authorities. The cope of dossiers is change to dossiers of registered products of General medicine, Specialty Care and Vaccines Portfolio.

Responsibilities:

• Identify requests for publishing in generic mailbox and analyze the request
• Record information related to Final Submission dossier(s) in planning tool and send acknowledgment of receipt e-mail to the requestor
• Verify table of content/ binder structure and documents to be included in the submission dossier, interact with the requestors & contributors to request clarifications/revisions and provide greenlight to move forward with publishing of the dossier in eCTD (electronic common technical document) format
• Prioritize submissions and negotiate submission dates with requestors if needed
• Monitor publishing of dossier, Quality control and Submission to Health Authorities
• Propose new ways of working, new processes to improve efficiency and the use of our cloud based tool
• Contribute to regulatory updates interpretation/implementation, procedures maintenance and new process implementation
• Monitor new guidelines/guidance from European Regulatory Authorities (HMA - Heads of Medicines Agencies, CMDh - Co-ordination group for Mutual Recognition and Decentralised Procedures \xe2\x80\x93 human, EMA- European Medicines Agency) and assess impact on internal processes and ways of working

Requirements:

• Finished Master\xe2\x80\x99s Degree in Pharmacy, Life Science or other related field and strong interested in Regulatory Affairs
• Project management experience in pharmaceutical industry - preferred in Regulatory Affairs
• Fluency in English & French is mandatory
• Proficient in the use of MS Word, PowerPoint, Excel
• Proficient in the use of collaborative work environment tools (eg. SharePoint)
• Rigor, adaptability, team spirit
• Ability to work with evolving technologies
• Ability to work in a matrix environment

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.

Sanofi