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Medical Regulatory Writer

2+ years
Not Disclosed
10 June 6, 2025
Job Description
Job Type: Full Time Education: PhD, MPharm, MBBS, BDS, MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.