Medical Regulatory Writing Job – at Sanofi, Apply Now!
Join Sanofi’s dynamic Global Hub in Hyderabad as a Medical Regulatory Writer, where your scientific acumen and writing expertise will help shape the future of global healthcare communication. This is your opportunity to contribute to high-impact medical documents and safety reports for one of the world’s leading pharmaceutical companies.
- Job Position: Medical Regulatory Writer
- Location: Hyderabad, India
About the Company
Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi globally.
About the Role
As a Medical Regulatory Writer, you will develop and review critical regulatory and safety documents such as PBRERs, Addendums to Clinical Overviews, Disease/Product ID Cards, Product Alerts, and clinical trial transparency reports. You’ll work in collaboration with global cross-functional teams, including Medical Affairs, Pharmacovigilance, and Regulatory Affairs, to ensure that all deliverables are of high quality, scientifically accurate, and compliant with international guidelines.
Key Responsibilities
- Write, edit, and review regulatory and safety documents, including PBRERs, ACOs, and SBS Q&A.
- Participate in document planning, data analysis, and content development.
- Maintain effective relationships with medical and scientific stakeholders.
- Track timelines, manage document submissions, and ensure audit readiness.
- Collaborate with cross-functional teams and support trial transparency submissions.
- Assist in SOP adherence, quality document evolution, and vendor coordination.
- Remain updated on global regulatory and Sanofi-specific medical writing standards.
Who Should Apply
- Education: PhD, Master’s, or Bachelor’s in Life Sciences, Pharmacy, PharmD, MBBS, BDS, BAMS, BHMS, MD
- Experience: Minimum 2 years in medical or regulatory writing in the pharma/healthcare industry
- Technical Skills:
- Expertise in writing/editing scientific content and summarizing data
- Familiarity with ICH, GVP, and GCP guidelines
- Experience with trial disclosure platforms (e.g., ClinicalTrials.gov, EUCTR)
- Strong document management, time management, and MS Office skills
- Soft Skills:
- Excellent communication and stakeholder management
- Ability to work independently and collaboratively in a global team
- Attention to detail and project ownership
Why Join Sanofi?
At Sanofi, you’re not just taking a job—you’re pursuing progress and transforming global health. Our inclusive culture fosters innovation, collaboration, and continuous learning. Whether you’re a scientific communicator or a strategic thinker, we help you evolve while making meaningful contributions to patient safety and medical excellence.
Keywords: Medical Regulatory Writer, Job Posting, Sanofi Global Hub, Regulatory Writing, Healthcare Industry
