Regulatory Affairs Officer - Ahmedabad, India - SWASTIK PLACEMENT AGENCY

    SWASTIK PLACEMENT AGENCY
    SWASTIK PLACEMENT AGENCY Ahmedabad, India

    1 week ago

    Default job background
    Full time
    Description

    Identified regulationsrelated toContent of ANDA, Patent and Exclusivity, Prior Approval Supplement (PAS), Changes to ANDA and ICH Q6-A Facilitated in Annual report preparation for several solid oral products Demonstrated Stability data review, BPR review, Validation report reviews and Human prescription drug labelling Preparation of labelling section 1.

    14 in module 1 of ANDA dossier Facilitated in preparation of several sections of Module 32s & 32p Hands-on experience with eCTD software (PharmaReddy)for SPL generation, registration of new drug product, sequence creation, uploading of modules for eCTD submission Submissions via ESG