Regulatory Affairs Officer - VIE Contract

at  Sanofi US

REGULATORY AFFAIRS OFFICER - VIE CONTRACT

• Location: Finland, Helsinki - Espoo office
• Target start date: 01/09/2024
  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.

SOFT AND TECHNICAL SKILLS:

• Strong team orientation.
• High degree of organizational skills.
• Good communication, coordination / facilitation and relational skills.

Education:

• PhD, Pharm Degree or MSc in Biology, Life Science, or related field of study, Master of Science in Regulatory Affairs.

Languages:

• Proficient in English written and oral communication skills.

• Coordinate of regulatory activities to support the product lifecycle or development plans and support submission task force.
• Coordinate of regulatory activities to support the Global Submission Plan with the global product regulatory team (GRT), track and update Global Simultaneous Submission plan (GSS).
• Participate in the preparation of consultations with authorities.
• Support the GRL for the meetings of the product regulatory team (GRT) composed of the different regulatory experts (Reg CMC, Reg Labeling, Regional Regulatory contacts, Regulatory Operations): preparation, meeting minutes, follow-up of actions.
• Support the GRL for the update of the document summarizing the Global Regulatory Product Strategy (GRPS).
• Support the local regulatory team in all relevant regulatory activities.