Dr. Jitendra Badjatya

Experience

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  MGRM Medicare Ltd.

  Jan 2009 - Jul 2010

  Regulatory Affairs Officer

  1. Dossier preparation or CIS and ASEAN Countries.2. Provide regulatory requirements to analytical and QC, QA, F & D, R & D, Logistic, Marketing and Manufacturing teams and ensure that information is interpreted correctly and for data generation3. Patent and Literature searching, Prior art search, separating relevant and non-relevant patents. 4. Preparation of SPC, PIL, MSDS, Licensing documents and Liasioning with regulatory authorities.

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  Brawn Laboratories Limited

  Jun 2010 - Jun 2011

  Regulatory Affairs Manager

  1. Dossier preparation, review and their timely submission for CIS, GCC, Latin America, African and ASEAN Countries.2. Critical assessment of data and extend support to Regulatory by ensuring timely availability of necessary documents for new submissions, variation, and renewals.3. Solving queries from different regulatory authorities of concerned countries. 4. Provide regulatory requirements to analytical and QC, QA, F & D, R & D, Logistic, Marketing and Manufacturing teams and ensure that information is interpreted correctly and for data generation5. Team Leading: Recruiting, providing Guidance and training the Project teams with regulatory requirements in order to obtain timely regulatory approvals for the products and review of the technology transfer documents.6. Patent and Literature searching, Prior art search, separating relevant and non-relevant patents. 7. Preparation of SPC, PIL, MSDS, Licensing documents and Liasioning with regulatory authorities.8. Compliance with respect to Quality and WHO-GMP Standards, Participate in Plant Inspection. Show less

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  Health Biotech Limited

  Jul 2011 - Aug 2013

  Regulatory Affairs Specialist

  PREVIOUS COMPANIES ROLES AND RESPONSIBILITIES:1. Dossier preparation, review and their timely submission for CIS, Middle East, Latin America, African and ASEAN Countries.2. Critical assessment of data and extend support to Regulatory by ensuring timely availability of necessary documents for new submissions, variation, and renewals.3. Solving queries from different regulatory authorities of concerned countries. 4. Provide regulatory requirements to analytical and QC, QA, F & D, R & D, Logistic, Marketing and Manufacturing teams and ensure that information is interpreted correctly and for data generation5. Team Leading: Recruiting, providing Guidance and training the Project teams with regulatory requirements in order to obtain timely regulatory approvals for the products and review of the technology transfer documents.6. Patent and Literature searching, Prior art search, separating relevant and non-relevant patents. 7. Preparation of SPC, PIL, MSDS, Licensing documents and Liasioning with regulatory authorities.8. Compliance with respect to Quality and WHO-GMP Standards, Participate in Plant Inspection. Show less

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  Montajat Veterinary Pharmaceuticals Co., Ltd.

  Oct 2013 - Jan 2017

  Deputy Manager - Regulatory Affairs

  1. Formulating regulatory strategy, eCTD and paper Dossier submission for approval (GCC, MENA, African and CIS Countries), maintenance of the regulatory approvals, handling of post-approval variations, support for smooth launch and uninterrupted supplies, liaison with regulatory authorities.2. Application type: New application, Renewals, & handling queries from technical sections.3. Ensuring compliance of products with the current regulations, monitoring of international legislation, CMC Specialist, guidelines and customer practices, planning and communicating with external agencies, compliance, harmonization, support and work with R & D, Quality Assurance, and Manufacturing.4. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions.5. Perform functions: Regulatory compliance, Planning, meet project timelines, Training, Risk management, act as Team leader and participate in Plant Inspection (SFDA). Show less

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  Umedica Laboratories Private Ltd.

  Feb 2017 - Jan 2020

  Regulatory Affairs Manager

  1. Formulating regulatory strategy, eCTD and paper Dossier submission for approval (Emerging market, EU & Australia), CMC review, maintenance of the regulatory approvals, handling of post-approval variations, support for smooth launch and uninterrupted supplies.2. Application type: New application, Renewals, Variations; handling queries from technical sections.3. Ensuring compliance of products with the current regulations, monitoring of international legislation, guidelines and customer practices, planning and communicating with external agencies, compliance, CMC Specialist, harmonization, Change control, support and work with R & D, Quality Assurance, and Manufacturing.4. Anticipate regulatory obstacles and emerging issues throughout the product life cycle and work with appropriate teams to develop solutions.5. Perform functions: Regulatory compliance, Planning, meet project timelines, Training, Risk management, act as Team leader and participate in Plant Inspection. Show less

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  Torrent Pharmaceuticals Ltd

  Dec 2019 - Jun 2023

  Scientist I
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  Emcure Pharmaceuticals Limited

  Apr 2023 - now

  Senior Manager RA