Executive – Regulatory Affairs (US ANDA / Russia CIS) @ J B Chemicals and Pharmaceuticals Ltd.
Responsible for preparation and compilation of ANDA as per check list provided by US FDA guidelines for to obtain the necessary authorization.
Preparation of e-CTD Modules 1,2,3 and 5 as per ANDA checklist
Arranging Documents like Letter of Authorization for DMF Holders for API / Packing material cGMP Certificate required for completion of ANDA.
Maintain awareness and knowledge of current US FDA, ICH guidelines/legislation and ensures best regulatory practice all time.
Preparing Documents for Annual Report, PADER submission, CBE-0, Labeling amendments,
Hands-on experience of eCTD Softwares for compilation of ANDA.
Review, analyze and prepare/compile documents generated by R&D, Site, QA and other related departments as per current regulatory requirements.
Handling queries from Regulatory Bodies from time to time.
To review Documents/support site during FDA Audit.