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Shilpa Kotecha

Shilpa Kotecha

Regulatory Affairs Associate

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  • Timeline

  • About me

    Global Regulatory affairs/CMC & Ancillary documentation management/Quality management systems

  • Education

    • Mumbai University Mumbai

      -
      Master of Science - MS Biochemistry

      Have completed my Masters in Life science (Biochemistry) by papers from T. N. Medical College, Mumbai central. Had worked for a project which involved detection of trace elements in Oral cancer patients as a part of curriculum for final year.

  • Experience

    • Cipla

      Dec 2005 - Sept 2009
      Regulatory Affairs Associate

      Worked as Regulatory affairs team member mainly for preparation of submission dossiers for LATAM region.

    • MACLEODS PHARMACEUTICALS LTD.

      Sept 2009 - May 2012
      Regulatory Affairs Executive

      Worked as Regulatory affairs executive. Was responsible for over all activities for CIS market submissions. Coaching and training of new comers for CIS market registration process. CTD dossier preparation, consignments and work orders, samples and standards, Dossier related queries for CIS region. Also prepared registration dossiers for Africa, Middle East and South East Asia markets. Prepared tender related documents for African countries.

    • Pharmalink

      May 2012 - Apr 2017
      Regulatory Affairs Executive

      Was working on Dossier strategy presentation for emerging markets of various countries on basis of source data provided by US based client. Was moved to another role of Ancillary documentation management team for same Client.

    • Genpact

      Apr 2017 - Jul 2024

      Have been assigned responsibility for Compilation and QC review of submissions for MAH name change, Site name change, Legal entity name change variations. Was working as senior team member for Ancillary documents management. Had responsibility of requesting, reviewing, compiling of Non - CMC as well few CMC documents such as CoAs, stability studies, chromatograms etc. for preparation of CTD dossier Module 1 and 3.2.R section. Was managing the team related activities in India office and also coaching and training new comers to Ancillary documentation team.

      • Regulatory Affairs Manager

        Apr 2022 - Jul 2024

      • Lead consultant Regulatory affairs

        Apr 2017 - Apr 2022

  • Licenses & Certifications

    • Lean

      Genpact