Regulatory Affairs Job at Sanofi | Apply Now For R&D Electronic Document Specialist Role
Sanofi, a global leader in healthcare and innovative medicine, is looking for an R&D Electronic Document Specialist to join its strategic Hyderabad Hub. This role is a vital part of the company’s mission to transform business performance while delivering life-changing medications to patients worldwide. For professionals seeking a high-impact regulatory affairs job, this position offers the opportunity to manage complex submission documents while building a long-term Sanofi career in a future-focused environment.
- Job Position: R&D Electronic Document Specialist
- Location: Hyderabad Hub, India.
- Functional Area: R&D / Regulatory Operations.
About the Company
Sanofi is a global pharmaceutical pioneer dedicated to chasing the miracles of science to improve people’s lives. A Sanofi career provides a springboard for innovation across every R&D department, supported by a diverse and inclusive workforce. Sanofi is committed to equal opportunities, embracing talent regardless of race, religion, or background, and fostering a culture where “being and thinking different” is valued to drive breakthroughs in life sciences jobs.
Job Overview
The Electronic Document Specialist (eDS) is responsible for the technical preparation and quality control of regulatory dossiers like eCTDs and INDs. This regulatory affairs job involves high-level formatting, submission-readiness validation, and the use of advanced technologies like Artificial Intelligence. You will serve as a technical expert ensuring that all documentation meets global specifications for electronic submissions.
Key Responsibilities
- Document Preparation: Format dossiers and reports to ensure submission-readiness according to global regulatory requirements.
- E-Submission Compliance: Ensure file naming conventions, metadata, and formats (INDs, CTDs) meet strict specifications.
- Quality Assurance: Conduct rigorous formatting quality checks to identify linking errors or inconsistencies.
- Document Management: Use EDMS tools to manage version control, track revisions, and ensure document integrity and security.
- Publishing Support: Assist in document compilation and report publishing in compliance with company and regulatory standards.
Qualifications Requirements
To excel in this life sciences job, candidates must possess a blend of technical precision and regulatory knowledge:
- Education: Bachelor’s degree or equivalent degree in regulatory affairs, sciences, related areas of study, and/or relevant experience
- Experience: Proven background in electronic documentation for clinical trials and registrations (e.g., CTDs).
- System Mastery: Proficiency in Veeva Vault RIM, EDMS, Adobe Acrobat, and Microsoft Office Suite.
- Technical Knowledge: Deep understanding of eCTD structure, XML tagging, metadata requirements, and file formats.
- Skills: Strong attention to detail for troubleshooting formatting, conversion issues, and ensuring version control.
- Communication: Fluency in English is mandatory to collaborate with cross-functional teams like CMC, Quality Assurance, and Clinical Development.
Choosing a Sanofi career means joining a future-focused team dedicated to bringing the miracles of science to life. This regulatory affairs job in Hyderabad is a perfect fit for specialists who thrive at the intersection of technology and compliance. As the industry evolves toward AI-driven documentation, Sanofi provides the platform to grow your expertise in life sciences jobs while impacting millions of lives globally. If you have experience in eCTD publishing and a background in sciences, apply today to discover extraordinary opportunities at Sanofi.
