Global Medical Expert – Regulatory Writing & Strategic Medical Content
Location: Hyderabad, India
Job Type: Full-time, Permanent
Work Mode: On-site
Experience Required: 5+ years
Compensation: Not specified; competitive and commensurate with experience
Job Summary
Sanofi is hiring a Global Medical Expert in Hyderabad to lead and support medical regulatory writing, benefit-risk assessments, and strategic medical content for global regulatory submissions. This role plays a crucial part in ensuring compliance with FDA, EMA, and international regulations while coordinating across Medical Affairs, Pharmacovigilance, and Global Regulatory teams. Ideal for professionals with MBBS/MD and strong experience in medical writing and clinical documentation across cardiology, metabolism, oncology, or infectious diseases.
Key Responsibilities
Provide expert medical evaluation and content for documents such as PBRERs, DSURs, Clinical Overviews, and Benefit-Risk Assessments
Draft and review regulatory documents, CTD modules, Briefing Packages, and compassionate use cases
Collaborate with cross-functional global teams (Medical, PV, Regulatory) to maintain marketing authorizations
Support extended synopsis writing with RWE experts and ensure SOP/GCP compliance
Oversee document quality, timelines, and adherence to internal/external medical writing standards
Guide execution of medical regulatory strategy and contribute to vendor coordination when necessary
Provide insights on global labeling, dossier management, and health authority responses
Participate in training, knowledge sharing, and support junior writers within the team
Maintain up-to-date knowledge on regulatory writing requirements, trends, and tools
Required Skills & Qualifications
Minimum 5 years of experience in pharmaceutical medical writing, medical affairs, clinical development, or pharmacovigilance
Experience in at least one therapeutic area: Cardiovascular, Metabolism, Diabetes, CNS, Oncology, Anti-infectives
Proficiency in writing and reviewing regulatory, scientific, and medical content
Strong expertise in CTD modules, SOP/GCP compliance, and benefit-risk documentation
Medical degree: MBBS required; MD preferred
Advanced knowledge of English (spoken and written)
Excellent stakeholder management, time management, and risk evaluation skills
Able to work independently and collaborate effectively in a cross-functional, international setting
Perks & Benefits
Be part of Sanofi’s global medical content innovation and strategy team
Exposure to regulatory submissions across major markets (FDA, EMA)
Access to world-class tools and training for continuous learning and development
Collaborative and inclusive workplace culture
Competitive compensation and benefits based on qualifications and experience
Meaningful work impacting patient access, safety, and global health outcomes
About Sanofi
Sanofi is a global healthcare leader advancing scientific innovation across immunology, rare diseases, vaccines, oncology, and more. With a strong commitment to data-driven research and digital healthcare, Sanofi empowers professionals to deliver better patient outcomes worldwide.
Work Mode
On-site – Hyderabad, India
Call to Action
Take your career to the next level in global regulatory science. Apply now to join Sanofi’s elite medical writing and strategic content team in Hyderabad and help shape the future of healthcare communications.
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