Global Regulatory Affairs Vaccines Strategist - VIE Contract

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Regulatory Affairs team as Global Regulatory Affairs Vaccines Strategist VIE.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities:

• Global Tasks :
• Coordinate regulatory activities to support the Common Technical Documents (CTD) task force, as preparation of pre-submission activities.
• Coordinate 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 global regulatory team (GRT) composed of the different regulatory experts (RegCMC, RegLabeling, Regional Regulatory contacts, Regulatory Operations): preparation, meeting minutes, follow-up of actions.
• Support the Global Regulatory Lead (GRL) for the update of the document summarizing the Global Regulatory Product Strategy (GRPS).
• Specific Country Tasks :
• Coordinate and contribute to the regulatory activities for dedicated products.
• Work with Canadian GRL and RS to support French or US product licensed in CA or CA manufactured products licensed world wide for new market authorizations, line extension presentation or Q&A facilitation, clinical- or Chemistry, Manufacturing and Controls (CMC) labeling variation submissions co-ordination in CA, US and EU markets.

About you

Experience:

• Previous experience in Regulatory Affairs would be a strong asset.
• Experience in the pharmaceutical industry is highly preferred.

Soft and Technical skills:

• Advanced MS Office skills (Excel in particular, Think Cell would be a plus).
• ​Good communication, coordination, and facilitation skills.
• Great organizational and multitasking skills.
• Strong team orientation.

Education:

• Master’s degree in Biology, Life Science, Regulatory Affairs or related field of study.
  

Languages:

• Proficiency in English.