Sanofi has announced an exciting opportunity for the position of Medical Regulatory Writer at its Hyderabad office. This role is ideal for experienced professionals with a background in medical writing, regulatory writing, pharmacovigilance, and scientific communications. Candidates with over two years of experience and qualifications in Pharmacy, Life Sciences, or Medicine are encouraged to apply.
As part of Sanofi Business Operations, the selected candidate will contribute to global regulatory documentation, safety reporting, and medical communication activities supporting Sanofi’s Specialty Care, Vaccines, General Medicines, Consumer Healthcare, and R&D businesses.
If you are looking for Medical Regulatory Writer jobs in Hyderabad, Medical Writing jobs in India, or Regulatory Writing jobs in Pharmaceutical companies, this opportunity offers excellent career growth within one of the world’s leading pharmaceutical organizations.
Job Details
| Particular | Details |
|---|---|
| Company | Sanofi |
| Position | Medical Regulatory Writer |
| Job Type | Full-Time |
| Location | Hyderabad, Telangana |
| Experience | 2+ Years |
| Department | Medical Regulatory Writing |
| Last Date to Apply | 31 August 2026 |
Key Responsibilities
The selected Medical Regulatory Writer will:
- Author and edit high-quality medical regulatory documents.
- Prepare medical sections of Periodic Benefit-Risk Evaluation Reports (PBRERs).
- Develop Addendum to Clinical Overview (ACO) documents.
- Prepare Disease and Product ID Cards.
- Manage Product Alerts and related documentation.
- Support clinical trial transparency activities.
- Publish study protocols, amendments, study results, lay summaries, and redacted documents on regulatory platforms.
- Collaborate with Medical, Pharmacovigilance, Regulatory Affairs, Biostatistics, Legal, and Corporate Affairs teams.
- Interpret scientific literature and summarize medical evidence.
- Ensure compliance with ICH, GCP, GVP, and global regulatory guidelines.
- Maintain inspection-ready documentation and regulatory archives.
- Coordinate with external vendors for regulatory writing deliverables.
- Contribute to continuous process improvement initiatives.
Educational Qualifications
Candidates with any of the following qualifications are eligible:
- B.Pharm
- M.Pharm
- Pharm.D
- D.Pharm
- B.Sc (Life Sciences)
- M.Sc (Life Sciences)
- MBBS
- BDS
- BAMS
- BHMS
- MD
- PhD (Life Sciences or related discipline)
Experience Required
- Minimum 2 years of experience in Medical Regulatory Writing or Pharmaceutical Regulatory Writing.
- Experience in scientific writing or pharmacovigilance documentation is preferred.
Required Skills
Applicants should possess:
- Medical writing expertise
- Regulatory writing knowledge
- Scientific literature review
- Medical editing skills
- Data interpretation
- Knowledge of ICH Guidelines
- Good Clinical Practice (GCP)
- Good Pharmacovigilance Practices (GVP)
- Medical communication
- Stakeholder management
- Vendor management
- Time management
- Risk management
- Excellent written and spoken English
- Ability to summarize complex scientific information
Preferred Experience
Experience working on:
- PBRER
- Addendum to Clinical Overview (ACO)
- Product Alerts
- Disease ID Cards
- Product ID Cards
- Trial Transparency Documents
- ClinicalTrials.gov submissions
- EUCTR
- EudraCT
- Lay Summaries
- Scientific communication projects
Why Join Sanofi?
Working with Sanofi offers:
- Opportunity to work with a global pharmaceutical leader
- Exposure to international regulatory writing projects
- Collaborative global medical and pharmacovigilance teams
- Career growth in Medical Writing and Regulatory Affairs
- Inclusive and diverse work culture
- Learning opportunities across multiple therapeutic areas
- Strong focus on employee development
How to Apply
