Ashok Chauhan

Experience

• 

  Promed Exports Pvt Ltd

  Jul 2007 - Mar 2009

  Research Associate

  Worked as Research Associate in Dep't of Medical Affairs

• 

  Ranbaxy

  Apr 2009 - Dec 2010

  Worked as Research Scientist at Ranbaxy Laboratories Limited in Department of Medical Affairs & Clinical Research Research Associate at Ranbaxy Laboratories Limited in Department of Medical Affairs & Clinical Research

  • Research Scientist

    Oct 2009 - Dec 2010

  • Research Associate

    Apr 2009 - Sept 2009
• 

  Novartis Consumer Health

  Jan 2011 - Aug 2015

  In OTC business unit as Regulatory Affairs Professional-II (Cough-Cold & Respiratory, i.e. CCR Franchise).Involved as regulatory responsible in Geo-expansion of respiratory medicinal product in Portugal, Switzerland, and most of the Latin American countries, for which coordinated for all the clinical dossier, pre-clinical dossier, quality dossier and prepared the module 1 documents.Also managing wider aspects of Global Regulatory Affairs. Involved in the life-cylcle management of product registration i.e variations, renewals, GMP recognitions etc... Show less

  • Regulatory Specialist - II

    May 2014 - Aug 2015

  • Global Labeling Manager

    Jan 2011 - Apr 2014
• 

  GSK Consumer Healthcare India

  Oct 2015 - Jul 2016

  CMC Regulatory Affairs Manager

  Currently managing the wider aspects of Global Regulatory Affairs. Involved in the life-cylcle management of product registration i.e variations, renewals, GMP recognition etc...Started working on the CMC activities for the Medical Devices and the Cosmetic Products.

• 

  PAREXEL

  Jul 2016 - Jul 2017

  Consultant - Commercialization

  # Managing evidence review projects, providing technical direction and overseeing day-to-day operational aspects of a project and scope# Create and execute project plans and revise as appropriate to meet the Client requirements# Key client contact for different projects across varied geographic areas# Prepare and review deliverables (technical reports and manuscripts) prepared by the team# Coordinate projects with teams across different locations of the company# Conduct outcomes research studies applying health economics, patient-reported outcomes, psychometrics, retrospective data analyses, epidemiology and health services research# Scientific content development/Medical writing# Support business development by working on proposals and related budget Show less

• 

  AstraZeneca

  Jul 2017 - now

  Reg BD Transition lead• Post Deal & Pre-Deal Activities: Support the Regulatory BD Lead and TA Reg teams in managing e.g., Regulatory kick-off meetings, population of Data Rooms• Provide Customer support: Provide expert advice, guidance and interpretation of matters pertaining to Transition Services Agreements (TSA) to ensure Transfer timelines are accurate and deliverable by the collective team and partners• Provide expertise: Using a comprehensive understanding of regulatory and PV processes and regulations and clear communication regarding the submissions• Represent AZ Externally: Represent AstraZeneca at external partner meetings• Drive Collaboration:o Working across functions to provide advice and support for commercial agreements, ensuring optimal and compliant Regulatory advice and inputo Work with Marketing Company post deal, providing advice and support for both the MC’s & our post deal partnerso Working with continuous improvement groups for process improvements• Provide onboarding and training: Develop updated training materials on AZ Regulatory Systems where necessary and deliver to Post Deal partner. Provide training to Reg Ex, partners and other functional groups e.g., Regulatory, Safety, OpsReg/CMC, IQVIA etc.• Champion a culture of continuous improvement:o Monitor internal and external stakeholders to support collaborations and process improvement by working with continuous improvement groupso Lead the development and/or enhancement of standards or techniques to improve the quality, compliance and efficiency of deliverables for the overall group• Management of deal agreements:o Provide oversight of the regulatory aspects of deal coordination and ownership of the management of new and existing partnerships and agreementso Champion clear communication and change management activities associated with processes and partnering initiatives Show less Reg BD Transition lead• Post Deal & Pre-Deal Activities: Support the Regulatory BD Lead and TA Reg teams in managing e.g., Regulatory kick-off meetings, population of Data Rooms• Provide Customer support: Provide expert advice, guidance and interpretation of matters pertaining to Transition Services Agreements (TSA) to ensure Transfer timelines are accurate and deliverable by the collective team and partners• Provide expertise: Using a comprehensive understanding of regulatory and PV processes and regulations and clear communication regarding the submissions• Represent AZ Externally: Represent AstraZeneca at external partner meetings• Drive Collaboration:o Working across functions to provide advice and support for commercial agreements, ensuring optimal and compliant Regulatory advice and inputo Work with Marketing Company post deal, providing advice and support for both the MC’s & our post deal partnerso Working with continuous improvement groups for process improvements• Provide onboarding and training: Develop updated training materials on AZ Regulatory Systems where necessary and deliver to Post Deal partner. Provide training to Reg Ex, partners and other functional groups e.g., Regulatory, Safety, OpsReg/CMC, IQVIA etc.• Champion a culture of continuous improvement:o Monitor internal and external stakeholders to support collaborations and process improvement by working with continuous improvement groupso Lead the development and/or enhancement of standards or techniques to improve the quality, compliance and efficiency of deliverables for the overall group• Management of deal agreements:o Provide oversight of the regulatory aspects of deal coordination and ownership of the management of new and existing partnerships and agreementso Champion clear communication and change management activities associated with processes and partnering initiatives Show less Lead Regulatory Project Manager• Contribute to the GRST regulatory strategy providing, procedural, documentation, submission planning and execution expertise• Prepare and manage the product plan, encompassing all global submissions• Leads the collaboration between the GRST and GRET and communicates the global strategy and strategic development considerations related to the product plan to the GRET• Lead GRST & GRET sub-teams, i.e. Cross functional Delivery teams for major activities such as divestments• Accountable for ensuring that a high performing GRET, in close collaboration with the GRST, delivers the product plan submission milestones and manages the regulatory procedures to support expedited drug development and approval• Accountable for allocating GRET RPM resources to project related activities, and clearly outlining GRET member responsibilitiesGlobal Labelling ManagementThis includes:• the maintenance of core labeling documents including the Core Data Sheet, and Core Patient Information Leaflet, including labelling history documents• the maintenance and corporate approval of EU SmPC and US PI and packaging component labeling while ensuring consistency with applicable core labeling documents and internal standards and SOPs• ensuring that updates to the core texts are completed, communicated to and implemented by MCs in a timely manner and deviations are agreed and documented appropriatelyRegulatory Project Management• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including: Submission delivery strategy of all dossiers and all application types per market and /or region• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex regulatory maintenance submissions from either a global and/or regional perspective Show less

  • Associate Director-II, Regulatory Business Development

    Apr 2022 - now

  • Associate Director-I, Regulatory Business Development

    Jun 2021 - Apr 2022

  • Senior Manager I - Global Regulatory Affairs

    Jul 2017 - May 2021