Exciting Opportunity: R&D Electronic Document Specialist at Sanofi 🌟Sanofi, a global leader in healthcare, is hiring an R&D Electronic Document Specialist in Hyderabad! If you’re passionate about regulatory submissions, document management, and cutting-edge technologies like AI, we want to hear from you! 🌐
About the Role 📝
As an Electronic Document Specialist within our Hyderabad Hub, you’ll play a crucial role in preparing and managing documents for regulators, ensuring Sanofi’s submissions meet the highest quality standards. You’ll be part of a dynamic team transforming healthcare and impacting millions of lives.
Main Responsibilities 📊
- Document Preparation: Create and format documents, dossiers (including eCTD binders), reports, and ensure submission-readiness according to regulatory guidelines.
- E-Submission Compliance: Ensure documents meet electronic submission specs (e.g., INDs, CTDs), including file formats, naming conventions, and metadata.
- Quality Assurance/Control: Conduct quality checks for accuracy, completeness, and compliance with Sanofi standards. Review documents for errors, linking issues, and make revisions.
- Collaboration: Work with cross-functional teams (regulatory affairs, nonclinical, clinical development, quality assurance, CMC, ITS) to gather documents and ensure submission-readiness.
- Document Management: Manage documents using Vault RIM systems, ensure version control, track changes, and maintain security.
- Publishing Support: Compile documents and publish reports, ensuring compliance with regulatory requirements.
About You 📚
- Experience: Electronic documentation preparation, regulatory submissions (e.g., CTDs) for clinical trials and registrations.
- Skills:
- Proficiency in Vault RIM, EDMS, Adobe Acrobat, Microsoft Office Suite.
- Understanding of eCTD structure, XML tagging, metadata requirements.
- Strong attention to detail, version control, and compliance.
- Familiarity with regulatory guidelines (INDs, NDAs/BLAs).
- Effective communication in English (written and spoken).
- Adaptability to new technologies (AI) and changing regulations.
- Education: Bachelor’s degree in regulatory affairs, sciences, or related areas.
Why Join Sanofi? 🌈
- Innovation Hub: Be part of Sanofi’s Hyderabad Hub, driving performance across R&D departments.
- Global Impact: Contribute to changing millions of lives through healthcare innovations.
- Growth Opportunities: Develop skills in regulatory submissions, AI-driven document management.
- Collaborative Culture: Work with diverse, cross-functional teams.
Job Details 📅
- Location: Hyderabad
- Type: Full-time
- Apply By: January 16, 2026 (28 days left)
- Job ID: R2836340
How to Apply 📧
Ready to make an impact? Apply now through the link below 👇🏻:
https://sanofi.wd3.myworkdayjobs.com/en-US/SanofiCareers/job/Hyderabad/R-D-Electronic-Document-Specialist_R2836340?shared_id=7391b0ad-701c-479d-8c85-db431309d68f
Conclusion 🌟
Join Sanofi and be part of transforming healthcare with cutting-edge technology and global impact! Apply now and take your career to the next level! 🚀
