As a Electronic Document Specialist within our Hyderabad Hub, you'll be responsible for preparing and managing documents for regulators while upholding Sanofi s long history of producing high-quality submissions. It s a chance for you to make an impact across the entire portfolio and ensure patients are receiving the care and medications they need to live healthy lives.
The eDS works in an setting in constant evolution and needs to be prepared to work with new technologies including Artificial Intelligence.
Main responsibilities:
- Document Preparation : Create and format documents, dossiers (including binders of authoring documents), reports, and perform submission-readiness validation according to regulatory guidelines and requirements for inclusion or not into the submission related activities (eg eCTD). This includes ensuring consistency in formatting, adherence to document templates, and compliance with Sanofi standards.
- E-Submission-ready Compliance: Ensure that all documents meet the specifications outlined for electronic submissions (eg INDs, CTDs),



including file formats, naming conventions, and metadata requirements.
- Quality Assurance/Control: Conduct formatting quality checks on documents to ensure accuracy, completeness, and compliance with regulatory Sanofi standards, including reviewing documents (eg linking errors, inconsistencies) and making necessary revisions.
- Communication and Collaboration: Collaborate with cross-functional teams, including regulatory affairs, nonclinical (including Research), clinical development, quality assurance, CMC, ITS and other stakeholders, to gather the necessary information and documents for ensuring submission-readiness of the documents.
- Document Management: Manage electronic documents throughout the document preparation process, including version control (eg locked documents, embargo), tracking changes, and ensuring document integrity and security by using document management systems or other electronic t

📌 R&D Electronic Document Specialist (Secunderabad)
🏢 Sanofi
📍 Secunderabad