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.
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