Sanofi is a leading global pharmaceutical company committed to improving health outcomes through innovative medicines, vaccines, and healthcare solutions. With a strong presence in over 100 countries, Sanofi focuses on Specialty Care, Vaccines, General Medicines, and Consumer Healthcare.
The Sanofi Global Hub in Hyderabad supports centralized processes for Medical, Regulatory, HEVA, and Commercial functions worldwide. This role offers an opportunity to work with cross-functional teams in a dynamic, inclusive workplace.
📌 Why Join Sanofi?
✔ Global leader in healthcare innovation
✔ Inclusive and diverse work culture
✔ Career growth in regulatory medical writing
✔ Impactful role in drug safety & compliance
Detailed Job Description
Job Title: Medical Regulatory Writer
Location: Hyderabad, India
Job Type: Full-time
Posting Date: July 25, 2025
Application Deadline: August 14, 2025
Requisition ID: R2815700
Key Responsibilities:
- Write, edit, and review high-quality safety documents, including:
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Addendum to Clinical Overview (ACO)
- Disease & Product ID Cards
- Product Alerts & Trial Transparency Docs
- Ensure compliance with ICH, GCP, GVP guidelines
- Collaborate with Pharmacovigilance, Regulatory, Medical, and Biostats teams
- Manage vendor relationships & stakeholder communications
- Track regulatory postings (e.g., CTG, EUCTR, EUDRACT)
Performance Metrics:
✅ Deliver on-time, high-quality regulatory documents
✅ Maintain audit & inspection readiness
✅ Stay updated on Sanofi policies & regulatory guidelines
Eligibility & Skills
Education & Experience:
- Advanced degree (PhD/MSc/BPharm/PharmD/MBBS/MD) in Life Sciences, Pharmacy, or Medicine
- 2+ years in regulatory/medical writing (pharma/healthcare industry)
Technical Skills:
✔ Medical/scientific writing & editing
✔ Data interpretation & literature screening
✔ Knowledge of ICH, GCP, GVP guidelines
✔ Proficiency in Microsoft Office & regulatory databases
Soft Skills:
✔ Strong communication & stakeholder management
✔ Ability to work independently & in teams
✔ Time & risk management
Language Requirement:
- Fluent English (written & spoken)
Benefits & Work Culture
Sanofi offers a progressive, inclusive work environment with:
- Competitive salary & benefits
- Global career growth opportunities
- Flexible & collaborative culture
- Commitment to diversity & inclusion
How to Apply
