Venkata Nagarjuna Regula

· Review, compile, and submit regulatory dossiers for new product submissions (ANDAs, NDAs) and post-approval submissions (supplements, amendments) for US and Egypt markets.

· To ensure all submissions meet regulatory requirements, with a focus on tablets, capsules, solutions and Injectables dosage forms.

· Requesting, collecting, accuracy review of documents from Plant QA (PDR, AMV, BMR, BPR, PVP/PVR, Hold time reports, Specifications, analytical procedures, COAs (API, Raw materials, packaging materials, in-process, finished release and Stability data).

· Review of documents received from the CFT’s

· eCTD preparation and submission to FDA.

· To monitor and track regulatory submission activities and ensuring that all tasks are completed according to regulatory timelines and business priorities and maintain regulatory databases and submission logs and ensuring accurate record-keeping and tracking.

· Collaborate with cross-functional teams, including R&D, Quality teams (QA, QC), and Project Management (PM), to obtain necessary documentation and data for regulatory filings.

· Evaluation of the changes and preparing the submission for supplements (CBE-0, CBE-30, PAS) and Annual reports.

· Preparation and submission of post-approval supplements and CMC (Chemistry, Manufacturing, and Controls) amendments.

· Ensuring submitted documents against original/current documents available at respective manufacturing sites for correctness and sharing observations, if any.

· Evaluation for acceptance of draft change proposal and requesting required documents with respective changes.

· Circulating the approval details to the concern departments and ensuring the post approval compliance as per the commitments given in the submissions.

· Maintain submission information according to the Regulatory Information Management (RIMs) system.

· Create and approve Material codes in MDM S4 HENA portal.

· Raising PR, preparing the POs and closing the PR & POs in SAP.

· Ensure all submissions comply with global regulatory requirements, including ICH, and other regional guidelines

· Review of CMC documents.

· Handling of post approval and pre approval changes related to stability.

· Review of data related to chromatograms and support to regulatory requirements.

· Responsible for coordinating with regulatory team regarding the responses for Submitted ANDA incomplete response, deficiency review letters and complete response (IR, DRL & CR)

received from FDA.

· Review of Specifications and STP’s related to RM, PM, FP, IP and Shelf life.

· Review of analytical documents related to Analytical Method Development and Validation activities for various Dosage forms like Tablets, Oral Solutions and Injectable.

· Preparation and Review of Stability studies Protocols/Compilation data.

· Initiation, Review and follow up of Quality Management Studies Activities- Change Controls, Incidents, CAPA.

· Review of Finished stage and In-process stage analytical reports.

· Preparation and review of technical reports like reports for elemental impurities and Residual solvents.

· Review and Approval of Analytical method validations and Method Verifications Protocols, Data and Reports.

· Review of Stability studies Protocols/Compilation data.

· Review of Electronic data Audit trails and System audit trails.

· Ensure data Integrity in all activities conducted in the laboratory.

· Review of Finished stage and In-process stage analytical reports.

· Review and follow up of Quality Management Studies Activities- Incidents, PNC’s.

· Stability studies Management - Samples Loading/Unloading/Samples tracking.

· Ensure data Integrity in all activities conducted in the laboratory.

· To ensure GLP’s followed in laboratory and cGMP systems.