Job Title: Senior Medical Regulatory Writer
Location: Hyderabad, India
Job Type: Permanent, Full-Time
Travel: As per business need
Estimated Salary: ₹15–25 LPA based on experience and qualifications
About the Role:
Join Sanofi’s Hyderabad hub as a Senior Medical Regulatory Writer and take charge of high-impact global medical documents. You will independently lead the creation and editing of regulatory content supporting global healthcare innovations across therapeutic areas like diabetes, cardiovascular conditions, and transplantation.
Key Responsibilities:
Writing & Document Development:
Write/edit critical clinical and safety documents (e.g., PBRERs, CSRs, Addendums to Clinical Overviews, ID cards, Evaluation Reports, Product Alerts).
Deliver high-quality regulatory documents aligned with global and internal standards.
Work independently with minimal supervision; mentor junior writers and peer-review their work.
Scientific & Regulatory Collaboration:
Collaborate with cross-functional global teams including Scientific Communication, Regulatory, Pharmacovigilance, and Corporate Affairs.
Maintain up-to-date knowledge of therapeutic areas and regulatory frameworks (ICH, GCP, GVP).
Proactively support stakeholders in Medical and Pharmacovigilance teams to ensure medical-scientific accuracy.
Process & Project Management:
Author and maintain compliance with medical regulatory requirements for supported countries.
Manage regulatory submissions (posting protocols, redacted docs, lay summaries) on platforms like CT.gov, EudraCT, EUCTR.
Lead vendor coordination and implement annual regulatory plans.
Ensure audit readiness and document tracking in internal systems.
Requirements:
Experience:
Minimum 5 years of experience in medical or regulatory writing within the pharmaceutical or healthcare industry.
Education:
Advanced degree in life sciences/pharmacy (PhD, Master’s, BPharma, PharmD) or medical qualifications (MBBS, MD, BDS, BAMS, BHMS).
Technical Skills:
Expert in medical/scientific writing and editing, literature screening, data interpretation.
Familiarity with GCP, ICH, GVP guidelines, and digital writing tools.
Knowledge of clinical regulatory platforms and requirements.
Soft Skills:
Strong stakeholder and vendor management abilities.
Excellent written and verbal communication skills in English.
Capability to work independently and in team settings.
Why Join Sanofi?
Be part of a globally respected biopharma leader accelerating access to groundbreaking care.
Thrive in a diverse and inclusive workplace where innovation meets impact.
Receive competitive compensation and benefits, including generous parental leave and healthcare.
Join a collaborative culture focused on continuous learning and development.
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