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Urmila Saner

Urmila Saner

Internship Trainee

Followers of Urmila Saner3000 followers
location of Urmila SanerDhule, Maharashtra, India

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  • Timeline

  • About me

    Pharmaceuticals || Regulatory Affairs || CTD Dossier || Regulatory Affairs Freelancer || ROW Market ||

  • Education

    • MIT WPU - School of Pharmacy pune

      2021 - 2022
      Post graduation diploma Regulatory affairs

    • SVKM's Institute of Pharmacy, Dhule

      2017 - 2021
      Bachelor of Pharmacy - BPharm Pharmacy First Class with Distinction

      Activities and Societies: Sports, Seminars, poster presentations

  • Experience

    • S. P. PHARMACEUTICALS

      Jan 2021 - Feb 2021
      Internship Trainee

    • Farbe Firma Pvt. Ltd.

      Nov 2022 - Aug 2023
      Regulatory Affairs Trainee

      Preparation & Submission of Dossier as per country specific guidelines.Review of documents like BMR, Stability Data, process validation, Finished Product Specifications & MOA etc.FDA Work- Application of PP, COPP, FSC & License Handling of Artworks

    • BDR Pharmaceuticals Int'l Pvt Ltd

      Aug 2023 - now
      Regulatory Affairs Officer

      Dossier Preparation & compilation as per country specific guidelines (CTD & ACTD format)Query Solving DCGI SubmissionFDA Work- PP , COPP , Form 29 ApplicationsArtworks Handling

  • Licenses & Certifications