Sanofi – Senior Medical Regulatory Writer | Hyderabad, India | Clinical & Safety Writing
Company: Sanofi
Location: Hyderabad, India
Job Type: Full-Time
Work Mode: On-site / Hybrid (global collaboration role)
Experience: 5+ Years (Regulatory Writing / Medical Writing)
Qualification: Advanced Degree (Life Sciences / Pharmacy / Medical)
Compensation: Not disclosed in the job description
Regulatory medical writing roles are among the most critical in pharma, especially for professionals working on clinical study reports, safety documents, and global regulatory submissions.
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Job Summary
Sanofi is hiring a Senior Medical Regulatory Writer to develop high-quality clinical and safety documents supporting global regulatory submissions and pharmacovigilance activities.
This role focuses on writing and reviewing regulatory documents such as CSRs, PBRERs, ACOs, and clinical evaluation reports, ensuring compliance with ICH-GCP/GVP guidelines and global regulatory standards.
You will collaborate with clinical, pharmacovigilance, regulatory, and biostatistics teams, making this a highly cross-functional and impactful role in drug development and lifecycle management.
This role is ideal for professionals aiming to grow in:
Regulatory Medical Writing
Clinical Research Documentation
Pharmacovigilance Writing
Global Regulatory Submissions
Key Responsibilities
Regulatory & Clinical Writing
Author and review:
Clinical Study Reports (CSR)
Periodic Benefit-Risk Evaluation Reports (PBRER)
Addendum to Clinical Overview (ACO)
Clinical evaluation reports
Product and disease ID cards
Prepare briefing documents and regulatory submission materials
Safety & Pharmacovigilance Documentation
Develop safety-related documents and product alerts
Write stand-by statements and Q&A documents
Support trial transparency and disclosure activities
Clinical Trial Transparency & Submissions
Manage posting of clinical trial data on:
ClinicalTrials.gov (CTG)
EUCTR / EUDRACT
Ensure compliance with transparency and disclosure regulations
Data Analysis & Scientific Interpretation
Participate in planning data presentation and analysis
Interpret clinical and scientific data for regulatory documentation
Summarize complex data into clear, compliant documents
Collaboration & Stakeholder Management
Work closely with:
Clinical teams
Pharmacovigilance teams
Regulatory and biostatistics teams
Liaise with global and regional stakeholders
Quality, Compliance & Process Management
Ensure documents meet:
ICH-GCP / GVP guidelines
Internal SOPs and regulatory standards
Maintain audit and inspection readiness
Track and archive documentation in compliance systems
Mentorship & Review
Peer-review documents for quality and consistency
Mentor junior medical writers
Support capability building within teams
Required Skills & Qualifications
Advanced degree in Life Sciences, Pharmacy, or Medical field
5+ years of experience in:
Regulatory medical writing
Clinical or safety documentation
Strong expertise in:
CSR, PBRER, ACO writing
Clinical trial documentation
Regulatory submission processes
Core Competencies:
Scientific data interpretation and analysis
Medical writing and editing skills
Knowledge of clinical research processes
Strong communication and stakeholder management
Regulatory Knowledge:
ICH-GCP and ICH-GVP guidelines
Clinical trial transparency requirements
Global regulatory frameworks
Preferred Skills (High-Impact SEO Keywords):
Regulatory Writing & Submission
Clinical Study Reports (CSR)
Pharmacovigilance Writing
Benefit-Risk Evaluation
Medical Affairs Documentation
Trial Disclosure & Transparency
Perks & Benefits
Work on global regulatory submissions and clinical programs
Exposure to international regulatory agencies and compliance systems
Opportunity to mentor and grow within medical writing teams
Career progression into senior regulatory or medical writing leadership roles
Collaborative global pharma environment
About the Company
Sanofi is a leading biopharmaceutical company focused on innovative medicines, vaccines, and healthcare solutions. With expertise in immunology, cardiovascular diseases, diabetes, and rare diseases, Sanofi is committed to advancing global healthcare through science and innovation.
Why This Role is High-Impact in Pharma Careers
The Senior Medical Regulatory Writer role is essential for:
Regulatory approvals and submissions
Clinical trial reporting and transparency
Safety documentation and compliance
This role provides exposure to:
Global regulatory agencies (FDA, EMA)
End-to-end clinical development lifecycle
High-impact scientific documentation
Career growth opportunities include:
Lead Medical Writer
Regulatory Writing Manager
Clinical Documentation Lead
Director – Medical Writing
Application Process
Apply via Sanofi careers portal
Highlight experience in:
CSR / PBRER / ACO writing
Clinical trial documentation
Regulatory submissions
Use keywords:
Regulatory Writing
Medical Writing
ICH-GCP
Pharmacovigilance
Call to Action
If you want to contribute to global regulatory submissions and high-impact clinical documentation, this is your opportunity.
Apply now and advance your career in medical regulatory writing with Sanofi 🚀
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