Regulatory Strategist job opportunity at Sanofi.

Bachelor's (B.A.)

Morristown, New Jersey, United States Of America

Morristown, Ne..........United States Of America

summarize with Ai

Enables the GRL by providing quality regulatory input and position to internal #business partners, including but not limited to the clinical development teams, #commercial and GRT for assigned projects. __ Contributes to the GRT for assigned #projects in alignment with the ream's one regulatory voice for providing #strategic input on the Target Product Profile (TPP), business planning, governance and committees. May be requested to lead GRT meetings. __ Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for lifecycle management of products. __ May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their remit, as needed. __ Accountable for developing the HA engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit. __ Leads submission team or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier/collaborates with regional lead where region-specific submissions are applicable. __ May lead HA meetings and preparations as designated. __ Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant. __ Leads the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.