Medical Regulatory Writer – Sanofi | Hyderabad, India
Location: Hyderabad, India
Job Type: Full-Time, Permanent
Work Mode: On-site
Experience Level: Mid-level (2+ years)
Salary: Not specified
Job Summary
Sanofi is seeking a Medical Regulatory Writer in Hyderabad, India, to create and manage high-quality regulatory medical documents for global use. In this role, you will collaborate with cross-functional teams in pharmacovigilance, clinical, and regulatory affairs, contributing to critical content such as PBRERs, Addendum to Clinical Overviews, and Product Alerts. This position is ideal for professionals with a background in medical writing, regulatory compliance, and pharmaceutical documentation who are ready to deliver impactful content aligned with GVP, ICH, and GCP standards.
Key Responsibilities
Author and edit high-quality regulatory documents including PBRERs, Addendum to Clinical Overviews, Disease/Product ID Cards, and Product Alerts
Contribute to trial transparency documentation and online postings (e.g., ClinicalTrials.gov, EUCTR)
Work collaboratively with global teams across Medical, Pharmacovigilance, Regulatory, and Corporate Affairs
Ensure timely, compliant delivery of medical content in line with Sanofi’s internal and external guidelines
Participate in planning data presentation and develop therapeutic area expertise
Manage Product Alert documents, including SBS QA (Stand-by Statements and Q&A)
Track document postings, maintain audit-ready files, and ensure regulatory documentation is updated
Contribute to continuous process improvement and assist other regulatory writers with training and mentoring
Required Skills & Qualifications
Minimum 2 years of experience in medical or regulatory writing in the pharmaceutical or healthcare industry
Advanced degree in life sciences, pharmacy, medicine, or related field (e.g., PhD, MPharm, MBBS, BDS, MD)
Familiar with ICH-GCP, GVP, and global regulatory standards
Strong command over medical terminology, data interpretation, literature screening, and scientific summarization
Excellent English writing and communication skills
Proficient in using computer applications, document tracking systems, and data retrieval tools
Ability to manage multiple stakeholders, meet deadlines, and work both independently and collaboratively
Perks & Benefits
Be a part of a leading global pharmaceutical company with a strong focus on innovation and digital transformation
Work on high-impact global projects across therapeutic areas
Continuous learning and development support through mentoring and team collaboration
Inclusive and equitable workplace with a commitment to diversity and healthcare excellence
Exposure to cross-functional global teams and regulatory ecosystems
Company Description
Sanofi is a global biopharmaceutical leader dedicated to improving health and transforming the lives of patients. With a strong presence in diabetes, immunology, cardiovascular diseases, and chronic care, Sanofi is at the forefront of regulatory innovation and digital healthcare solutions.
Work Mode
On-site – Hyderabad, India
Call to Action
Are you a skilled medical regulatory writer ready to contribute to impactful global healthcare content? Join Sanofi and help shape the future of pharma communication.
Apply today and be part of a team where your writing supports real-world medical progress.
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