Principal Medical Regulatory Writer

Job title: Principal Medical Regulatory Writer

About the job

Our Team:

Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.

Main responsibilities:

Independently write and/or edit/analyse/compile/summarize high-quality clinical and safety documents for timely submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities, in compliance with internal and external standards and guidelines, including complex Clinical Study Reports (CSR), complex CTD submission documents (Clinical Overview [CO]...