Experience

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  Dr. reddy's laboratories

  May 2006 - Dec 2009

  Research associate

  Worked for Active Pharmaceutical Ingredients (API) development, and supporting to review of S1 to S7 sections while preparing the DMF for US and EUROPE Markets.Hands one experience in review of stability study protocols and its raw data. Knowledge on assigning re-test period of drug substance. Preparation of write-up of impurity profile documentation. Hands-on experience of setting up of specifications right from the key starting materials, intermediates and drug substance.

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  Makrocare clinical research limited

  Jan 2010 - Jun 2012

  Cmc-regulatory affairs, executive

  • Renewal and Variation submissions for European markets (Regulated and non regulated markets), Annual updates, Post approval changes for US market • Experienced with International renewals by preparing different type of dossiers i.e. International Registration File (IRF), ASEAN CTD (ACTD), International CTD (iCTD) and European CTD (ECTD) as required by the Health Authorities.• Review and compilation of Module -2 & 3 (CMC Section) as per CTD and e-CTD formats.• Review documents in-line with regulatory requirements (Testing monographs [specifications], Analytical Reports, Process Validation Reports, Protocols and Stability data).• Review of Stability Data.• Effectively interacting with global colleagues (production, QC and QA) for getting the required documentation.• Attending weekly telecons with US and Europe folks. Show less

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  Cipla

  Jun 2012 - Mar 2013

  Management role - regulatory affairs (us market)

  • Review and compilation of Module – 2 and Module – 3 (CMC Sections) as per CTD and e-CTD formats.• Knowledge on variation filings like Prior Approval supplements, CBE-30’s, CBE-0’s etc., to US FDA.• Preparation and submission of Annual Reports, Amendments and Supplements for ANDAs.• Preparation, review and compilation of DMFs (CTD submission) to US markets.• Review documents in-line with regulatory requirements (Testing monographs [specifications], Analytical Reports, Process Validation Reports, Protocols and Stability data).• Review of Analytical Method Validation Reports.• Review and Making of Technology Transfer Dossiers.• Review of Stability Data.• Effectively interacting with colleagues of production, QC and QA for getting the required documentation.• Knowledge in the design/preparation of Specifications for different Dosage forms.• Knowledge in the preparation of Stability /Reconstitution/Compatibility Protocols. Show less

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  Tata consultancy services-gsk regulatory operations

  Apr 2013 - Nov 2016

  Team lead

  Core Responsibilities: • Maintaining the GSK electronic documentation management system throughout their life-cycle, providing technical support in preparing the study related documents and ensuring compliance with GSK technical standards for publishing activities• Performs Assembler tasks within the document publishing system, creating publications, modifying outline, assigning and transforming documents, and adding cross references • Performs Publishing tasks within the electronic publishing system, adding special sheets, applying rules and publishing. Performs QC tasks within the electronic publishing system and QC of the published output by the QC materials prepared by team and client• Create and assemble client deliverable documents and submissions using standard word processing and publishing systems and utilities (CoreDossier, ISIToolbox, Acrobat)• Takes lead role in preparing full application submission builds. Troubleshoots issues with backbone builds. • Receive and deliver client information/documents, with significant supervision. Provide alternatives for completing assigned tasks. Show less

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  Parexel international

  Nov 2016 - Apr 2019

  Manager-regulatory publishing services

  • Provides guidance to project team members • Works within broad project guidelines and facilitates issue and conflict resolutions • Prioritizes own work load and may prioritize the work load of the project team in order to achieve the project scope and objectives • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action• Regularly communicates with direct reports on the status and execution of their projects. Provides ongoing guidance and support especially with the resolution and escalation (if needed) of issues • Completes activities and may delegate activities within project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction • Facilitates client decision making by framing issues, presenting options and providing objective business advice • Collaborates with colleagues, as needed, to discuss and facilitate resolution of problems or conflicts. Provides guidance as needed to lower level colleagues on appropriate methods of executing project activities • Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office products; Adobe Acrobat and plug-ins; document management systems; publishing technology Show less

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  Parexel international clinical research private limited

  May 2019 - Apr 2021

  Senior manager -program manager regulatory operations

  • Client Relationship• Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence• Manage the day-to-day project activities and resources• Monitor staff performance and complete performance reviews• Provide status reporting regarding project milestones, deliverable, dependencies, risks and issues, communicating across leadership• Act as an internal quality control check for the project• Manage ongoing quality control and participate in quality issue resolution• Coach, mentor, motivate and supervise project team• Deliver appropriate and effective executive level communication Show less

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  Merck kgaa, darmstadt, germany

  Apr 2021 - Mar 2022

  Senior manager at merck kgaa (regulatory submission management & publishing)

  • Leading all operational publishing and submission management activities at GRA Operations India/Bangalore. Including implementation of Veeva Vault Publishing• Training coordination, including onboarding of new hires and coach and mentor the people in the offshore site.• Co-ordinate with Leadership Team, Facilities and IT teams and ensure availability of all necessary infrastructure, both in terms of office space as well as IT needs.• Responsible for delivery of high-quality publishing, submission- and document management services, performance, and value in the business of executing GRA programs and projects• Manage and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle• Create and update submission packages and Submission Content Plans for submissions to Health Authorities. Show less

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  Merck healthcare, electronic city phase-1, bangalore

  Mar 2022 - Nov 2024

  Associate director at merck kgaa (regulatory submission management & publishing)

  • As an Associate Director, managing a team of GRA submission management and publishing experts at GRA Operations in India/Bangalore.• Ensure compliance with Health Authority requirements, functional SOPs, and other internal guidance.• Streamline submission processing by guiding and harmonizing across functional area within Veeva Vault.Main interfaces:Internally:• GRA Operations Management Team• SBS Leadership Team• Regulatory Project Manager• Global Regulatory Lead• Country Regulatory Affairs• R&D Informatics• Other Global Regulatory Affairs functionsExternally: Service Providers Show less

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  Clinchoice

  Nov 2024 - now

  Director- regulatory services
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  Clinchoice

  -

  Director- regulatory services