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Global Regulatory Portfolio Simplification Coordinator - VIE Contract

Global Regulatory Portfolio Simplification Coordinator - VIE Contract

SanofiBudapest
17 days ago
Job description

Global Regulatory Portfolio Simplification Coordinator - VIE Contract

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

Main responsibilities :

  • Support divestment lead with pre-closing activities for divestment projects and post-closing regulatory work-stream as part of the divestment projects..
  • Support the development of regulatory strategy including Marketing Authorization Transfer plan and the transfer of regulatory responsibilities, including MAT plan implementation, local dossier transfers to the partners, and management of regulatory information internally and externally.
  • May represent Global Regulatory Affairs and provide regulatory support to key stakeholders, and support or lead internal and external regulatory requests by collaborating with regulatory and cross-functional stakeholders.
  • Collaborate with the regulatory stakeholders to receive relevant regulatory updates & information and assess impacts at various stage of the divestment projects including MA transfer process.
  • May support pruning initiatives originating from the Global Portfolio Rationalization (GPR) process and / or divestment projects.
  • Ensure timely communications of relevant topics and impacts to the project teams and up through GRA senior Management.
  • Research and analyze regulatory information and maintain current regulatory knowledge of regulatory procedures and changes globally.
  • Ensure compliance with all internal and external requirements and procedures and may propose improvement to operating policies / processes, as appropriate.

About you

Experience :

  • First experience in Regulatory Affairs, preferably in pharmaceutical industry.
  • Soft and Technical skills :

  • Good communication, analytical, presentation and negotiation skills.
  • Proactive with problem-solving mindset.
  • Ability to work within multi-functional environment.
  • Ability to manage multiple projects with strict timelines.
  • Proficient in MS : Word, Excel, PowerPoint.
  • Education :

  • Master’s Degree in Regulatory Affairs, Pharmacy, Life Science (Chemistry, Biology etc.).
  • Languages :

  • English fluent, French is only a plus.
  • 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 , discover

    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 and check out our Diversity Equity and Inclusion actions at !

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