How you’ll spend your day
Candidate having background in Regulatory Affairs (RA) writing.
Proficient in Module 2 preparation of documents
Module 2 includes writing sections of – 2.4 nonclinical overview, 2.5 clinical overview, 2.6 Nonclinical Written and Tabulated Summary and 2.7 Clinical Written and Tabulated Summary as per specific market requests
Knowledge in extensive literature search supporting basic elements based on SmPC of reference product reference product, safety and efficacy and bioequivalence study summary
Knowledge on reliable databases like Embase, Clinical pharmacology, Cochrane Library, PubMed, ScienceDirect, Micromedex and similar
Categorization of literature references according to sub-sections of module 4 and 5
Good knowledge to interpret templates for writing sections as final submission documents on English
Having exposure to Electronic data Capture tool like GRIDS etc to import expert reviews and supporting final submission
Your experience and qualifications
Experience: 3-8 years in RA Writing
Qualification: Master of Pharmacy (Pharmacology)
