PHARMAFull-time
Senior Medical Regulatory Writer
HYDERABAD (IN)ONSITEPOSTED: 8/18/2026
PHARMAFull-time
HIRING ORGANIZATIONSANOFIPharmaceuticals / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Author and edit high-quality regulatory submission documents to support marketing authorizations, renewals, and product maintenance, including Clinical Study Reports (CSR), Common Technical Document (CTD) modules, and Clinical Evaluation Reports (CER).
Lead and coordinate end-to-end Periodic Safety Reporting (PSR) activities, authoring medical sections of Periodic Benefit-Risk Evaluation Reports (PBRER) and Addendum to Clinical Overviews (ACO).
Plan, organize, and execute data presentation strategies and document kick-off meetings in alignment with cross-functional line functions and regulatory timelines.
Draft and review Stand-By Statements and Question & Answer (SBS QA) documents to manage emerging Product Alerts.
Manage clinical trial transparency deliverables, coordinating the preparation and posting of trial summaries, redacted protocols, and lay results on registries like ClinicalTrials.gov and EUCTR/EudraCT.
Conduct comprehensive quality and consistency reviews across peer-authored regulatory deliverables, resolving clinical discrepancies.
Technical & Domain Standards
Comprehensive mastery of clinical regulatory writing, pharmacovigilance concepts, aggregate safety reporting, and drug development lifecycles.
In-depth adherence to Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), ICH guidelines, and global Health Authority submission standards.
Proficiency in Electronic Document Management Systems (EDMS), particularly Veeva Vault, covering document versioning, approval workflows, and archival.
Support Health Authority audit and inspection readiness, participating in CAPA investigations and remediation for regulatory findings.
Leadership & Cross-Functional Collaboration
Act as an operational and scientific writing SME, mentoring junior medical writers and onboarding new team members through buddy programs.
Liaise seamlessly with cross-functional global and local stakeholders across Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics, and Medical Affairs.
Drive operational excellence, risk mitigation, and process standardizations within Sanofi Business Operations.
Benefits & Total Rewards
Opportunity to work within a leading global biopharmaceutical organization advancing breakthrough medicines and vaccines.
Competitive total rewards structure with annual performance-linked bonuses and comprehensive medical coverage.
Inclusive global workplace benefits including at least 14 weeks of gender-neutral parental leave and structured continuous learning programs.
REQUIRED VERIFIED SKILLS
Medical Regulatory Writing
Clinical Study Reports (CSR)
PBRER
Periodic Safety Reports (PSR)
Addendum to Clinical Overviews (ACO)
Pharmacovigilance
ICH Guidelines
GCP
GVP
CTD Submissions
Veeva Vault
Clinical Evaluation Reports (CER)
COMPENSATION & REWARDS
₹12.0L - 22.0L per annum
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
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