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Regulatory Affairs Officer - VIE Contract

Synthorx

Synthorx

Legal
Helsinki, Finland
Posted on Thursday, June 13, 2024

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.


About the job

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Regulatory Affairs Officer in our Regulatory Affairs team you’ll work closely with the Franchise Global Regulatory Lead (GRL) who is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their product(s) in order to meet corporate and business objectives, the GRL being the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team. This unique VIE opportunity will allow you to work both on global level and local level. Globally you will work within the Global Regulatory Affairs Department of the Sanofi Vaccines unit, participating in the missions of the Global Regulatory Affairs Franchise Vaccines Traveler Endemic. Locally you will work within the Finnish Regulatory Team, conducting regulatory activities for the affiliate.

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:

  • 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.


About you

Experience:

  • Previous experience in Regulatory Affairs would be an asset; pharmaceutical industry experience is preferred.


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.


Why choose us?


iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.

#LI-EUR

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!