Senior Medical Regulatory Writer – Hyderabad, India
Job Summary:
Sanofi is hiring a Senior Medical Regulatory Writer for its Hyderabad location. This is a key role for professionals with over 5 years of experience in regulatory medical writing within the pharmaceutical or healthcare sector. The position involves authoring, reviewing, and editing clinical and safety documents in compliance with international guidelines like GVP, ICH-GCP, and regulatory standards. If you're looking to work on impactful global documents while collaborating with world-class teams, this role offers an excellent opportunity in a science-led, patient-focused company.
Location: Hyderabad, India
Work Mode: On-site
Experience Required: 5+ years
Salary/Compensation: Not explicitly mentioned; competitive and based on experience
Key Responsibilities:
Author and review high-quality clinical and safety regulatory documents including PBRERs, ACOs, CSRs, Disease and Product ID Cards, Clinical Evaluation Reports, and Briefing Packages
Collaborate with medical, pharmacovigilance, regulatory, and corporate affairs teams
Independently plan data analysis and document strategy
Peer-review medical writing outputs from team members
Assist in trial transparency documentation for global regulatory sites (e.g., CTG, EUCTR, EUDRACT)
Maintain compliance with internal SOPs and international guidelines
Develop therapeutic area expertise and mentor junior writers
Maintain inspection readiness of all documentation and systems
Track submission and publication timelines across platforms
Required Skills & Qualifications:
5+ years of experience in medical regulatory writing within pharma or healthcare
Strong knowledge of ICH-GCP, GVP, and clinical trial reporting standards
Hands-on experience with document types: CSRs, PBRERs, ACOs, ID Cards, CTAs
Familiarity with tools like MedDRA, clinical databases, and PV documentation platforms
Excellent English writing, editing, and verbal communication skills
Strong project management and stakeholder collaboration abilities
Experience working with cross-functional teams across geographies
Proficient with medical literature screening and scientific data interpretation
Attention to quality, compliance, and timelines
Perks & Benefits:
Work in a globally recognized pharmaceutical company
Engage in impactful projects that reach global markets
Collaborative work environment with opportunities for skill development
Exposure to digital tools and AI-driven healthcare innovation
Competitive salary and performance-based rewards
Access to internal training and knowledge-sharing programs
About Sanofi:
Sanofi is a global biopharmaceutical leader focused on human health. In India, Sanofi Business Operations provides central support across specialty care, vaccines, general medicines, and R&D. With a mission to transform scientific innovation into life-changing treatments, Sanofi empowers its teams to make a global impact in chronic disease management, immunology, and beyond.
Apply Now
Take the next step in your regulatory writing career. Join Sanofi and contribute to shaping the future of healthcare.
Ready to apply? Visit Sanofi Careers or your preferred job platform and submit your application today.
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