Global Regulatory Team Lead – Early Immunology & Information

08/07/21

Location

Technologiepark-Zwijnaarde 21, Gent, Belgium

Vacancy

About the Opportunity

Join Sanofi Genzyme Global Regulatory Affairs (GRA) team in a newly created role as Global Regulatory Team Lead – in this position, you are responsible for the development as well as life cycle management strategies for the assigned project/products within the Immunology and Inflammation therapeutic area.

This role in open in several locations: Amsterdam NL, Diegem BE, Gent BE, Cambidge US, Chilly-Mazarin FR.

About Sanofi

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence. We want to focus on those areas where we know we are making a difference. 

About growing with us

In this role you will…

  • Represent GRA as a core member of the cross functional project team and Global Brand team and provide overall regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business on regulatory issues for the project(s)

  • Ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS)

  • Work transversally to ensure a properly functional regulatory sub-team and facilitate the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries

  • Be accountable to present the global regulatory strategy/position to senior management / governance committees as needed  

  • Collaborate with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program & TPP and develop region specific labels 

  • Ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed

  • Research and analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes. Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate

  • Position can evolve into management responsibilities

About you

Qualifications/ Education & work experience

  • Bachelor's degree and at least 6.5 years in Regulatory Affairs

  • 5+ years of experience in regulatory affairs ideally in immunology and/or biology

  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance

  • Ability to understand the global pharmaceutical marketplace and familiarity with medical terminology

  • Leadership, communication, negotiation, strategic skills

  • Independent, ability to adapt to new environment and constant change quickly

  • Oral and written in English, another language is an asset

Inspire your Journey: what Sanofi can offer you:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team

  • An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management)

  • An individual and well-structured introduction and training when you onboard

  • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully

  • As a globally successful and constantly growing company, Sanofi provides international career paths as well

This is our Sanofi. Discover yours.

If you feel you have the required experience please apply NOW, alternatively contact sandra.rombi@sanofi.com directly for more details.

https://www.sanofi.com/en/careers/

Own your future. Make your move!

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