Experience

Merck India
• India
• Pharmaceutical Manufacturing
• 200 - 300 Employee
• Specialist License Management

  • Oct 2020 - Present


GENPACT

• United States
• Insurance
• 1 - 100 Employee

• Lead Associate

  • Jul 2017 - Oct 2020

  Timely processing and compilation of regulatory information in accordance with requirements & regulations in ROW market to ensure high quality regulatory submissions. • Maintaining renewal dates, initiating renewal projects and ensuring dispatch of applications for renewal to HAs before the expiry of associated marketing authorization. • Work cross-functionally and in collaboration with key stakeholders both internal (e.g. publishing) and external (e.g. Client, local regulatory partners) • Reviewing Queries, as and when received by the MOH. Co-ordinating, Arranging appropriate documentation, Authoring and Submission of Response to Queries • Evaluation and Timely Submission of Variation applications. • Co-ordinating and conducting Client Product status update meetings including preparation of Meeting Agenda and Minutes. • Imparting training to New Joiners. • Reporting volumes, timelines, process metrics; supporting overall project deliverables. • Planning & management of all allocated projects and ensuring timely delivery of these projects. Show less



IDA Foundation

• Netherlands
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Officer - Regulatory and Quality Affairs

  • Dec 2014 - Jun 2017

  • Registration as per planning - basic dossiers - review and request for deficient documents within 15 days of the receipt of the fabricant dossier. • Preparation of country specific dossiers, questionnaires, query replies, renewals, fiche techniques, planning and submission of variations - as per deadlines given. • Communication with suppliers regarding requested items, developments in dossier requirements and registration overviews. • Performing trend analysis as planned. • Ensure timely updation of IWs for different countries as per the latest registration guidelines, • Conduct and maintain records on samples requested and dispatched for registration. • Arranging for dispatches of dossiers and samples for registration - as per the deadlines given. • Approving Products of Suppliers as per Quality Guidelines. • Conducting Verification Audits of Suppliers to assess and ensure good quality documentation Show less



Ajanta Pharma Ltd

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Associate - Formulation and Development

  • Oct 2012 - Dec 2014

  • Product Development in Ophthalmics. • Preparation and Issuance of License Information Forms (LIFs) to the In-House Licensing Department for procuring Test and Manufacturing Licenses. • Patent search and evaluation, literature review on formulation projects relevant for LIF preparation. • Coordinating with various departments to ensure formulation compliance to Pharmacopoeial Changes (Current Additions/Omissions). • Coordinating with various departments for various Shelf Life Revision activities i.e. Review Stability Data, provide relevant data to CQA for raising Shelf Life Revision Forms (SLRFs), track its approval, reply to queries and raise Change Control to implement the same. • Quality Management System (QMS): Handling of QMS system by initiating Change Controls (CCs), tracking its status, query replies, ensuring timely completion of Impact assessment Points and effective CC Closure. • Compilation of R&D write-ups for submission to Directorate of Scientific and Industrial Research (DSIR) and Company Annual Reports. • Handling of R&D Inventory Control System wrt Raw Material Bill of Material (RM BOM) Updation. • Knowledge of PDR preparation for Dossier Submission. • Knowledge of ICH Guidelines. Show less