Lead, R&D Document Standards & Integrated Services

As Lead, R&D Document Standards & Integrated Services within our R&D team, you will be part of our Submission & Document Services Platform that supports critical regulatory submissions across Sanofi's portfolio. In this role, you will be responsible for driving operational excellence across the R&D organization for document authoring and standardization efforts.

Based in the US, you will work closely with our global teams, including our Hyderabad Hub, colleagues throughout R&D, and the Digital organization to revamp our document management business processes, evaluate and integrate improved technology for R&D authoring, and drive continuous improvement initiatives. This role is pivotal in streamlining workstream management for R&D activities in support of eCTD acceleration and harmonization while ensuring cross-functional collaboration and operational efficiency across our global operations.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities

Strategic Leadership & Governance

• Define and own the long-term strategy for all document standards, template governance, and submission-ready authoring across the global organization encompassing all

• R&D Authoring functions

• Standardize the preparation of documents intended for regulatory submission, ensuring alignment with regional and global Health Authority requirements across all submission types (e.g., NDA, MAA, IND, BLA, CTD)

• Establish and lead a singular governance and quality control model for R&D encompassing document templates, including review cadence, approval workflows, and access controls to ensure quality at the source

• Develop, version, and maintain Operational Procedures (OPEs) for template governance in alignment with GxP and regulatory standards

• Drive continuous optimization of the template library to ensure efficiency, compliance, and alignment with evolving Health Authority requirements

• Define and enforce clear template ownership, accountability, and maintenance responsibilities across various functions within R&D – including clinical, non-clinical, pharmacovigilance, regulatory and CMC.

• Represent the Submission & Document Services Platform in governance committees and cross-functional initiatives, advocating for process optimization and standardization

Operational Excellence & Standardization

• Lead the ongoing rationalization and harmonization of document templates across R&D ensuring a lean, well-governed, and consistently maintained library of documentation required for dossier submission.

• Establish and sustain a single source of truth for formatting standards, ensuring consistent visual identity and style application across all R&D dossiers and authoring platforms

• Lead cross-functional working groups — spanning Clinical, Nonclinical, Regulatory/Labeling, Quality, and PSPV — to drive workstream-specific alignment and continuous improvement

• Partner with Digital in the management of style assets (including but not limited to .dot files and toolbar plug-ins) to ensure seamless author access and adherence to formatting standards

• Create, maintain and monitor dashboards to track operational metrics and provide ongoing visibility to leadership on program health and performance

• Develop and maintain standardized document preparation workflows specifically designed to meet submission requirements across multiple regulatory jurisdictions (e.g., FDA, EMA, PMDA, Health Canada, etc.)

• Implement submission readiness checklists and quality review processes within Global Submissions management to ensure documents meet formatting, content, and structural requirements prior to dossier compilation

Technology Integration & Innovation

• Partner with the eGSM lead, Digital and DDAI to evaluate, recommend, and implement tools and technologies that improve the ef