Medical Regulatory Writer Opportunity – at Sanofi, Apply Now!
Sanofi is hiring an experienced Medical Regulatory Writer in Hyderabad, India, to contribute to high-impact global medical documents, safety reports, and regulatory deliverables. If you are a skilled life sciences writer with strong analytical, regulatory, and scientific communication skills, this opportunity will allow you to make a real difference in global healthcare documentation standards.
- Job Position: Medical Regulatory Writer
- Location: Hyderabad, India
- Department: Global Medical Regulatory Writing (Sanofi Global Hub)
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.
Medical Regulatory Writer Opportunity – Key Responsibilities
- Author and edit safety documents such as PBRERs, Addendums to Clinical Overview (ACO), Disease & Product ID cards, trial transparency documents, and product alerts.
- Collaborate with cross-functional teams in Medical, Pharmacovigilance, Regulatory, and Corporate Affairs to develop customized content.
- Ensure content compliance with ICH, GVP, GCP, and Sanofi global quality standards.
- Track and post clinical trial documents to CT.gov, EUCTR, EudraCT, etc.
- Support audit readiness through thorough documentation, archival, and reporting processes.
- Mentor and support junior medical writers in knowledge sharing and training.
Medical Regulatory Writer Opportunity – Candidate Requirements
- Education: PhD, MSc, BPharm, PharmD, MBBS, BDS, BHMS, BAMS, or equivalent life sciences degree
- Experience: Minimum 2 years in medical or regulatory writing in a pharmaceutical/healthcare setting
- Skills:
- Strong command of English (written and verbal)
- Excellent medical writing, editing, and scientific interpretation skills
- Proficient with ICH, GVP, GCP guidelines, and submission platforms
- Advanced proficiency in MS Office and scientific databases
- Ability to manage timelines and interact with global stakeholders
Pursue Progress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. At Sanofi, we provide equal opportunities to all regardless of various factors. Let’s pursue progress together.
Keywords: Medical Regulatory Writer, Sanofi Global Hub, Job Opportunity, Regulatory Writing, Healthcare Industry, Stakeholder Management
