Job title: Senior Medical Regulatory Writer
Hiring Manager: Head Medical Regulatory Writing / Team lead
Location: Hyderabad
% of travel expected: Travel required as per business need
Job type: Permanent and Full time
About the job
Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India and is set up to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CMO, R&D;, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, Market Access, and Commercial organizations in Sanofi, globally.
Main responsibilities:
Write and/or edit high-quality documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities including simple Clinical Study Reports (CSR), straightforward CTD submission related documents , medical sections of Periodic Benefit-Risk Evaluation Reports, Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards,



and clinical evaluation reports, product alerts, trial transparency documents, and other relevant document with expertise. Delivery of high-quality documents on time and in compliance with internal and external standards and guidelines. Works on documents with some supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews.
Essential Job duties and responsibilities:
Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
Develops and maintains TA expertise.
Reviews content created by peers’ writers. Collaborates effectively with global or local cross functional teams e.g., Medical writing global or local teams, Pharmacovigilance teams, Regulatory Teams, Corporate Affairs Teams & others, based on the documents assigned.
Conduct project Kick-off meetings and align line functions on

📌 Senior Medical Regulatory Writer (Hyderabad)
🏢 Sanofi
📍 Hyderabad