Sanofi Group Associate Director GRTL, Oncology in Cambridge, Massachusetts
The Global Regulatory Team Lead is part of the Global Regulatory Affairs (GRA) organization within the Sanofi Genzyme Global Business Unit (GBU).They are responsible for developing long and short-term regulatory strategies for the projects and products under their accountability. The GRTL is responsible for the development as well as life cycle management strategies for the assigned project/products.
Major activities include:
Represents GRA as a core member of the cross functional project team and Global Brand team and provides 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).
The GRTL will 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)
The GRTL will work transversally to ensure a properly functional regulatory sub-team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
The GRTL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed.
The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP. The GRTL will also work with the labeling strategist and regions to develop region specific labels.
The GRTL will 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 recommend improvement to operating policies/processes, as appropriate.
Depending on the program assignment, the GRTL may also serve as the US Regulatory Lead. This includes the management of local submissions and FDA communication.
Bachelor's degree and at least 5 years in Regulatory Affairs or relevant industry experience
Master’s, PharmD, PhD degree and at least 3 years in Regulatory Affairs or relevant industry experience
Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.
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