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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.

Education

  • 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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