Job Title:
R&D Senior Electronic Document Specialist
Company:
Sanofi
Location:
Hyderabad, India
Full-Time, Permanent
About the Job:
As a Senior Electronic Document Specialist (eDS) at Sanofi's Hyderabad Hub, you’ll be responsible for creating, managing, and preparing regulatory documents for global submissions. You will work in a dynamic, technology-forward environment that embraces innovations like Artificial Intelligence to support regulatory excellence and ensure submission-readiness.
Main Responsibilities:
1. Document Preparation & Formatting
Create and format regulatory documents, dossiers, and reports (e.g. eCTD).
Ensure submission-readiness by following company and regulatory formatting standards.
2. E-Submission Compliance
Ensure all documents adhere to electronic submission specifications (e.g., INDs, CTDs), including correct file types, naming conventions, and metadata tagging.
3. Quality Assurance
Conduct formatting checks, correct errors, and ensure consistency and compliance with regulatory standards and Sanofi's internal guidelines.
4. Collaboration & Cross-functional Support
Work closely with Regulatory Affairs, Clinical Development, CMC, Quality Assurance, and ITS to coordinate document preparation and gather required inputs.
5. Document Management
Manage version control, embargo periods, and secure handling of documents using EDMS tools.
Assist in document migration during mergers/acquisitions.
6. Publishing Support
Assist in compiling and publishing reports and documents in line with Sanofi and regulatory standards.
7. Regulatory Monitoring
Stay updated with evolving global regulatory guidelines and electronic documentation requirements.
Monitor and implement new industry best practices.
8. Training and Guidance
Train internal teams on document preparation guidelines and best practices for submission-readiness.
9. Continuous Improvement
Identify inefficiencies in document workflows and propose improvements to enhance speed and accuracy of document readiness.
About You:
Experience & Skills
Prior experience in electronic document management in the pharmaceutical or life sciences industry.
In-depth knowledge of regulatory submission formats and requirements (e.g., FDA, EMA, eCTD).
Skilled in EDMS tools, Adobe Acrobat, Microsoft Office Suite, and Vault RIM systems.
Strong understanding of XML tagging, file specifications, and metadata in e-submissions.
Excellent attention to detail and ability to maintain consistency and quality.
Technical troubleshooting capabilities in document formatting and submission prep.
Experience in cross-functional team collaboration and communication.
Education
Bachelor’s degree (or equivalent) in Regulatory Affairs, IT, Life Sciences, or a related field.
Languages
Fluent in English (written and spoken).
Why Join Sanofi:
Mission-Driven Impact: Contribute to life-saving research and help patients receive critical therapies.
Career Development: Advance your career through global opportunities, promotions, and internal mobility.
Rewarding Culture: Benefit from a thoughtful rewards package that values your work.
Innovative Environment: Be part of a future-ready, supportive, and diverse R&D community.
Equal Opportunity Statement:
Sanofi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, gender identity, or veteran status.
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