Senior Medical Regulatory Writer – Hyderabad, India
Location: Hyderabad, India
Work Mode: On-site
Experience Level: Senior (5+ years)
Salary/Compensation: Not explicitly mentioned; industry-competitive based on experience
Job Summary
Sanofi is seeking a Senior Medical Regulatory Writer to join its Hyderabad-based Global Hub. In this role, you will author and edit a wide range of high-impact safety and clinical documents, including CSRs, PBRERs, ACOs, and ID Cards, while supporting global medical and pharmacovigilance initiatives. You will work cross-functionally with clinical, regulatory, and corporate teams, bringing expertise in GVP, ICH-GCP, and clinical documentation to ensure compliance, clarity, and global impact.
Key Responsibilities
Write, review, and edit clinical and safety regulatory documents such as:
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Addendum to Clinical Overviews (ACOs)
Clinical Study Reports (CSRs)
Disease/Product ID Cards
Briefing packages and trial transparency documentation
Participate in planning and structuring data for clinical presentations and submissions
Develop therapeutic area (TA) knowledge and support team expertise
Review content written by peer writers for accuracy and compliance
Collaborate with global and local teams across medical, regulatory, PV, and corporate affairs
Ensure audit- and inspection-readiness of all documentation
Track postings of clinical trial data on global portals such as CTG, EUCTR, and EUDRACT
Required Skills & Qualifications
Minimum 5 years of experience in regulatory or clinical medical writing within pharmaceuticals or healthcare
Strong knowledge of:
ICH-GCP and GVP
MedDRA terminology
PV and regulatory systems
Proficient in medical data interpretation and literature review
Ability to edit and summarize scientific information for diverse audiences
Skilled in time management, project tracking, and stakeholder communication
High proficiency in English (spoken and written)
Familiar with posting and managing trial data submissions and updates
Working knowledge of SOP compliance and global regulatory requirements
Perks & Benefits
Opportunity to work with a globally recognized pharmaceutical company
Involvement in strategic, global documentation for high-impact medicines
Cross-functional collaboration with international teams
Access to digital innovation and AI-driven healthcare solutions
Internal learning, mentoring, and development programs
Competitive compensation based on experience and performance
Professional growth within a strong scientific and regulatory environment
About Sanofi
Sanofi is a global healthcare leader dedicated to transforming scientific innovation into life-changing treatments. With a robust presence in chronic disease care, vaccines, immunology, and oncology, Sanofi empowers its teams to improve access and deliver health solutions at scale across global markets.
Call to Action
Ready to contribute your expertise to global healthcare advancements? Apply now and take your regulatory writing career to the next level at Sanofi. Visit the official Sanofi Careers page or apply through your preferred job platform.
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