Vijay Sonar Email and Phone Number

• • Provide support to compliance activities viz. CMC change controls, gap analysis of CMC documents against current regulatory and GMP requirements in association with QA, Supply chain and technical excellence teams• Perform final technical quality review and submit the dossiers in EU (DCP, MRP and National filing) and WHO markets• Dispatch submission to the relevant authority (e-CTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority• Perform post-submission processing activities such as receiving acknowledgment from the clients, authority of submission receipt; communicating submission receipt to key stakeholders;• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.• Evaluate the comments and compile the response to agency’s queries in within timeline to attain the approvals and co-ordinate with client/stakeholders.

• University approved Mentor of PG student (Quality Assurance & Regulatory Affairs)• University approved mentor for the certified course of IPR and Regulatory Affairs.• Subject expert for Audit and Regulatory Affairs, Quality Managements System, IPR, Pharmaceutical Jurisprudence.

I have completed my PhD in Life Environmental and Drug Science (Pharmacy Section). My research work was mainly focused on HIV-1 RT inhibitors. We have isolated 40 different phyto-constituent. Complete structural elucidation was done using 1D and 2D NMR. This work has been published in European Journal of Medicinal Chemistry and Journal of Natural Products. I got an opportunity to represent my research work at international conferences held at Cracovia (Poland), Budapest (Hungary). During the PhD tenure I went to University of Porto, Portugal as a visiting PhD student, for specialize training (3 months) on Biochemical assay. I have received the recognition of "PhD Europaus"Received full scholarship for PhD and training from University of Cagliari, Itlay.

• Review of the analytical raw data for its completeness, integrity and compliance with regulatory requirements.• Preparation of reports of the chemical analysis and submission of completed reports for QA approvals.• Preparation and review of standard operating procedures (SOPs), and development of guidance documents for internal processes, using regulatory guidelines. Also, involved in initiating change control, deviation and assessment of change control.• Handling and investigation of OOS, NCR, and CAPA for raw material, packaging material, and chemicals• Actively involved in the regulatory audits of USFDA and MHRA