Senior Medical Regulatory Writer – Hyderabad, India | Sanofi
Sanofi is hiring a Senior Medical Regulatory Writer in Hyderabad, India for professionals experienced in regulatory medical writing, clinical documentation, and pharmaceutical regulatory submissions. This role is part of Sanofi Business Operations, which supports global teams across Specialty Care, Vaccines, General Medicines, Consumer Healthcare, and R&D functions.
As a Senior Medical Regulatory Writer, you will develop and review high-quality regulatory and clinical documents used for pharmaceutical regulatory submissions and safety reporting. The role focuses on preparing complex documents such as Periodic Benefit-Risk Evaluation Reports (PBRER), Clinical Study Reports (CSR), Addendum to Clinical Overviews, clinical evaluation reports, and regulatory briefing packages.
You will collaborate with clinical teams, pharmacovigilance teams, regulatory affairs, biostatistics, and corporate affairs departments to ensure documents meet global regulatory standards. The position also involves mentoring other writers, reviewing scientific content, and ensuring compliance with international regulatory guidelines such as ICH, GCP, and GVP.
Write and edit regulatory and clinical documents including PBRER, ACO, CSR, and clinical evaluation reports.
Prepare medical sections for regulatory submissions and clinical trial documentation.
Manage product alerts, safety documentation, and trial transparency postings on platforms like ClinicalTrials.gov and EUCTR.
Review scientific content created by other medical writers to ensure accuracy and compliance.
Collaborate with clinical, regulatory, pharmacovigilance, and medical teams globally.
Interpret clinical data and summarize complex scientific information for regulatory audiences.
Ensure all documentation follows global regulatory guidelines and company compliance standards.
Support regulatory strategy by contributing to medical regulatory writing plans and deliverables.
The estimated salary for a Senior Medical Regulatory Writer in Hyderabad is typically around ₹16 LPA – ₹25 LPA, depending on experience in regulatory submissions, clinical documentation expertise, and pharmaceutical industry background.
Experience: 5+ years of experience in regulatory medical writing within the pharmaceutical or healthcare industry.
Education: Advanced degree in Life Sciences, Pharmacy, Medicine, or related discipline.
Technical Skills: Knowledge of ICH guidelines, GCP/GVP standards, clinical documentation, scientific data interpretation, and medical editing.
Skills: Strong analytical thinking, stakeholder collaboration, and scientific writing capabilities.
Language: Excellent written and spoken English.
Sanofi is a global healthcare company focused on developing innovative treatments for chronic diseases, immunology, diabetes, and cardiovascular conditions. Employees work in a collaborative and technology-driven environment where scientific expertise and innovation help deliver life-changing medicines worldwide.
Sanofi also promotes diversity, equal opportunity, and continuous professional development, providing employees with opportunities to grow while contributing to global healthcare advancements.
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