Job Title: Senior Medical Regulatory Writer
Location: Hyderabad, India
Company: Sanofi
Work Type: On-site
Compensation: Not disclosed
Job Summary
Sanofi is seeking an experienced Senior Medical Regulatory Writer to join its growing operations in Hyderabad. This is a high-impact role ideal for professionals with a background in regulatory writing, pharmacovigilance, and clinical documentation. You will play a pivotal role in authoring and reviewing documents such as PBRERs, CSRs, clinical overviews, and more to support global medical and regulatory submissions. The role requires domain expertise, independent project handling, and collaboration with cross-functional teams across the pharmaceutical lifecycle.
This is a strategic opportunity to contribute to Sanofi’s mission of advancing therapies for chronic diseases, immunology, and specialty care—where your words can shape the future of healthcare.
Key Responsibilities
Independently write, edit, and review a wide range of regulatory and clinical documents:
PBRERs, CSRs, ACOs, ID Cards, clinical evaluation reports, briefing packages, lay summaries
Provide technical and scientific expertise in content development for medical and pharmacovigilance teams
Collaborate closely with global and local Medical, Regulatory, PV, Biostatistics, and Legal teams
Mentor junior writers and act as a peer reviewer to ensure high-quality deliverables
Plan document content and structure based on data analysis and regulatory standards
Ensure compliance with ICH, GVP, and internal Sanofi writing guidelines
Track document submissions on platforms such as CT.gov, EUCTR, and EudraCT
Maintain document readiness for audits and inspections; ensure version control and archival
Required Skills & Qualifications
Minimum 5 years of experience in regulatory medical writing within the pharmaceutical or healthcare industry
In-depth knowledge of ICH-GCP, GVP, and regulatory frameworks
Strong command of writing and reviewing clinical and safety documents such as PBRERs, CSRs, CTAs
Proficiency in using document submission tools and regulatory portals (e.g., EudraCT, CT.gov)
Experience with MedDRA, scientific literature screening, and data interpretation
Excellent written and spoken English communication skills
Proficient in Microsoft Office, literature databases, and other medical writing tools
Ability to manage time, risks, and cross-functional collaborations efficiently
Perks & Benefits
Work in a global pharma leader focused on innovation and patient-centric care
Opportunity to lead and mentor in high-impact medical writing projects
Collaborative work culture with exposure to cutting-edge research and regulatory science
Access to digital tools and AI-driven platforms to enhance productivity
Professional development in a cross-disciplinary, high-performance environment
Company Description
Sanofi is a global healthcare leader focused on transforming scientific innovation into life-saving treatments. With a strong presence in vaccines, specialty care, general medicines, and digital health, Sanofi is committed to delivering better outcomes for people worldwide. Its Hyderabad hub is central to delivering medical, regulatory, and operational excellence.
Work Mode
On-site – Hyderabad, India
Call to Action
If you are an experienced medical regulatory writer ready to contribute to life-changing therapies and global healthcare innovation, apply now via Sanofi Careers. Help write the next chapter of better health..
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