Pradhan Kapadia

Experience

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  BioGenomics Ltd.

  Sept 2013 - Nov 2014

  Trainee (Regulatory Department)

  As a fresher I was very exited to pitch into the world of regulatory submissions. I started with the Indian Biosimilar submissions. It was a breathtaking experience to learn on the larger biological molecule and its product development. Curiosity in biosimilars helps me to understand the non-clinical and clinical studies as well.⮞ Responsible for assisting and compilation of Clinical trial Application Phase III as per CDSCO Guidelines. Worked on the 4 Biosimilars products.⮞ Responsible for preparing the Module 3 (CMC data) for the various biosimilars of insulin and its analogues.⮞ Reviewing the Quality data of the Drug Product and Drug Substance ensuring it as per the given standards and specification.⮞ Preparing the Toxicological Study Protocol for Parenteral Formulation as per ICH guidelines.⮞ Responsible for the Document Management system (Maintaining and tracking)⮞ Preparation of Import application for drugs from various countries (Form 11 License).⮞ To prepare application for Form 29 and renewal of the licence.⮞ To prepare regulatory department documents as per the requirements. Show less

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  Genpact Pharmalink

  Dec 2014 - Jun 2015

  Technical Associate (Regulatory Submissions)

  Learning of European submission (EU) has started with this position. Although, having very short tenure at this organization, I had got opportunity to explore the EU submission. My interest for electronic submission was seeded from this role. I have learned label review as well from this role.⮞ Responsible for the US and EU eCTD submissions.⮞ Responsible for the reviewing the Clinical Trial label for the different European Union Countries as per the EMA or National Regulatory Agency guidelines.⮞ Responsible for the Dossier Conformance Project Review (Variation Gap Analysis).⮞ Nees (Non electronic eCTD Submission) and eCTD software publishing. Show less

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  Torrent Pharmaceuticals Ltd

  Jun 2015 - Apr 2018

  Scientist II (Regulatory Submissions)

  Experience for scientist II was a career defining. I have got chance to work on standalone regulatory submissions in the various Rest of the World (ROW), European Union (EU) and USA (USFADA). With this role I got the through understanding of the submission process of the various countries. I also got chance to learn eCTD software and ultimately becoming expert in regulatory publishing. Along with this has also faced the regulatory and quality audits and successfully cleared.⮞ Compilation of the ANDA dossiers and deficiencies responses as per USFDA regulatory requirements for US market.⮞ Responsible for the submission/extension registration of a product to the other emerging markets like ASEAN, AFRICAN, EU and ASIA.⮞ Responsible for the compilation and review of the post approval submission like variations and annual report for the global market.⮞ Co-ordinate with various cross functional team members for collecting the documents required for compilation of ANDA and responding to Agency/Customer deficiencies and other applicable submissions.⮞ Responsible for updating the regulatory data base by the mean of electronic tools like DMS, regulatory information management system (RIMS) etc.⮞ Uploading and formalization of ANDA in eCTD format using eCTD dossier management software.⮞ Responsible for keeping track records like registered product history, Registration certificates, commitments to the agency, renewal dates, annual report submission etc.⮞ Submission publishing activity in eCTD Format for region like US and EMEA, for all modules. ⮞ Trouble shooting of the query based on the validation criteria. Show less

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  Emcure Pharmaceuticals Limited

  Apr 2018 - Sept 2019

  Regulatory Affairs Executive

  Expanding my experience towards USFDA submission, I had got opportunity to work on more number of ANDA submission. I enjoyed my work throughout ANDA submission process, right from the product development. In my added job responsibility, I had got to work on validation of eCTD publishing software.Key Roles and Responsibilities:⮞ Compilation, review and publishing of ANDAs applications.⮞ Responsible for the post approval and life cycle management i.e post approval submissions.⮞ Coordinating with the different stack holders for timely submission of ANDA Application.⮞ Maintenance of regulatory database and information system. ⮞ Maintaining and updating document track for ANDA compilation.⮞ Solving validation errors and rectification of errors of eCTD software as per validation criteria.⮞ Ensure high quality of publishing by performing bookmarking, hyper linking and TOC preparation for easy navigation throughout the dossier.⮞ Conducting ANDA adequacy audit.⮞ To provides input into strategy and contributes to regulatory plan. Show less

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  Fortrea

  Oct 2019 - now

  Associate Manager, Regulatory Submissions

  Moving into the clinical trial regulatory submission have been exciting. My work focus on achieving the regulatory approval, planning/strategizing submissions and collaborating with cross-functional team. Understanding the needs of clients and helping them to have the speedy approvals.Key Roles and Responsibilities:⮞ Plan, compile, review and submission of initial Clinical Trial Application (CTA) and life cycle management of the clinical study.⮞ Applying and maintenance of study specific Import License.⮞ Plan, organize and collaborate with team for Subject Expert Committee (SEC) meeting with CDSCO (India).⮞ Managing post approval maintenance submissions like Protocol Amendment, Minor amendment, EOT notification, periodic study progress reports, etc.⮞ Registering the study to the public registry website and its maintenance⮞ Review of the Clinical documents like Study Protocol, IB, IMPD, ICFs etc.⮞ Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.⮞ Assure compliance with regulatory requirements in relation to assigned projects.⮞ Participate in project development and regulatory strategy planning sessions. ⮞ To participate independently in client meetings and will proactively liaise with clients on regulatory submission issues.⮞ Excellent knowledge of EUCTR submissions.⮞ Supporting Local Ethic committee (EC) submission. Resolving queries from EC. Show less