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

Synthorx

Synthorx

Legal
Ghent, Belgium
Posted on Thursday, December 21, 2023

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

Target start date: 01/04/2024

Responsibilities:

  • Support the GRL for the meetings of the product regulatory team composed of the different regulatory experts (RegCMC, RegLabeling, Regional Regulatory contacts, Regulatory Operations): preparation, meeting minutes, follow-up of actions including
  • Develop the document summarizing the Global Regulatory Product Strategy (GRPS)
  • Assist in management and conduct of the Global regulatory activities for assigned projects in line with regulatory requirements. Preparing, compiling, reviewing and processing the regulatory submissions including both pre-approval and submissions amendments/supplements, annual & study reports, investigator brochures, etc.
  • Support the compilation, development, submission, and maintenance of worldwide regulatory filings
  • Track regulatory project status and informational documents
  • Coordinate required documentation in coordination with partners or Functional groups
  • Support operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant

Requirements:

  • Master of Science in Regulatory Affairs
  • Experience preferably in Regulatory Affairs
  • Good communication, coordination / facilitation and relational skills
  • Proficient in English written and oral communication skills
  • Solid knowledge of MS Office software
  • Ability to have a rapid and solid expertise in electronic document management systems (e.g. Veeva vault, Plai)
  • Organisation skills, entrepreneurial
  • Flexibility, creativity & enthusiasm
  • Motivated and open-minded, able to work in a team and interacting on cross-cutting and multicultural subjects

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.