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Medical Regulatory Writer

2+ years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time Education: PhD, MSc, BPharma, PharmD, MD, BDS, BAMS, BHMS 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 – Hyderabad (Full-Time, On-site)

Location: Hyderabad, India
Company: Sanofi Global Hub
Work Mode: On-site


Job Summary

Sanofi is seeking a skilled Medical Regulatory Writer with over 2 years of experience to support the preparation of high-quality, compliant regulatory documents including PBRERs, Addenda to Clinical Overviews, ID Cards, and Trial Transparency reports. This role is ideal for professionals with a strong background in regulatory medical writing, scientific communication, and stakeholder collaboration within the pharmaceutical and healthcare industry.


Key Responsibilities

  • Author and edit safety documents, PBRERs, clinical overview addenda, product alerts, and trial transparency content.

  • Maintain up-to-date knowledge of ICH-GCP, GVP guidelines, and regulatory standards.

  • Plan and analyze data presentation in collaboration with mentoring medical writers and stakeholders.

  • Collaborate with global medical, pharmacovigilance, biostatistics, and regulatory teams.

  • Assist in needs analysis, planning, and implementation of regulatory writing deliverables.

  • Track document postings and maintain compliance for audit-readiness.

  • Support regional teams and vendors for seamless execution of medical writing projects.


Required Skills & Qualifications

  • Experience: Minimum 2 years in medical or regulatory writing within the pharmaceutical or healthcare domain.

  • Education: Advanced degree in Life Sciences, Pharmacy (PhD, MSc, BPharma, PharmD) or Medical degree (MBBS, MD, BDS, BAMS, BHMS).

  • Strong technical writing and editing skills.

  • Solid understanding of ICH-GCP, GVP, clinical research processes, and data interpretation.

  • Excellent English communication (written and verbal).

  • Proficient in stakeholder management, vendor coordination, and cross-functional teamwork.

  • Comfortable working independently and within global teams.


Perks & Benefits

  • Be part of a global pharmaceutical leader driving healthcare transformation.

  • Access to cutting-edge AI and digital innovation tools.

  • Opportunities to work on diverse therapeutic areas including immunology and chronic disease care.

  • Dynamic and collaborative workplace culture.

  • Inclusive environment with equal opportunity policies.


Company Overview

Sanofi is a global healthcare company committed to improving lives through innovative medical research, patient-focused solutions, and digital transformation. With operations in over 100 countries, Sanofi is a trusted name in the pharmaceutical and biotechnology sectors, pushing boundaries across vaccines, specialty care, and general medicine.


Work Mode

On-site – Hyderabad, India


Call to Action

Ready to advance your career in regulatory medical writing? Apply now to join Sanofi and be part of a passionate team making a global impact in healthcare.