PHARMAFull-time
Senior Medical Regulatory Writer
HYDERABAD (IN)ONSITEPOSTED: 8/17/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Author and edit high-quality regulatory submission documents including Clinical Study Reports (CSR), CTD submission documents, and PBRER medical sections.
Lead end-to-end Periodic Safety Report (PSR) activities, including stakeholder alignment, data collection, authoring, validation, and quality checks.
Collaborate with cross-functional global teams across Medical, Regulatory, Pharmacovigilance, and Corporate Affairs departments.
Prepare stand-by statements and Q&A documents for product alert management and manage clinical trial transparency postings.
Conduct peer reviews, mentor junior medical writers, and support Health Authority inspections, audits, and CAPA development.
REQUIRED VERIFIED SKILLS
Medical Writing
Regulatory Submissions
Clinical Study Reports (CSR)
Periodic Benefit-Risk Evaluation Reports (PBRER)
Pharmacovigilance
ICH-GCP
GVP
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.
TEAM SIZE: Approximately 90,000 employees
INDUSTRY: Pharmaceuticals / Biotechnology
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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