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Regulatory Affairs Associate - VIE Contract (W/M)

Synthorx

Synthorx

Legal
Vernier, Switzerland
Posted on Friday, December 22, 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: Regulatory Affairs Associate - VIE Contract (W/M)

Target start date: 01/04/2024

Responsibilities:

  • Work with the Germany Switzerland Austria (GSA) multi country team on a wide range of regulatory activities in life cycle management of prescription medicines and medical devices
  • Contribution to implement labelling updates and language switch
  • Preparation of variation documents for selected products
  • Database maintenance
  • Monitoring of the compliance of regulatory tools and processes
  • Management of Health Authority (Swissmedic) requests and portal updates/reports
  • Participation in Regulatory and transversal projects

Requirements:

  • Master’s degree in pharmacy is preferred, or other life science disciplines
  • Experience in international and/or country regulatory affairs incl. knowledge of Swiss/EU regulation would be an advantage
  • Proficiency in MS Office package and databases (VEEVA Vault, eCTD)
  • Good project management and organizational skills
  • Accurate and precise working attitude
  • Strong time management and prioritization skills
  • Ability to work cooperatively with others across (multifunctional and multicultural) the organization to achieve shared objectives
  • Fluent in English and a very good level of German and French
  • Italian would be a strong asset

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.