Global Regulatory Team Lead – Early Immunology & Information
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/
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