Parmeshwar Ghadge

About Parmeshwar Ghadge

1.Good knowldge of Dossier submission and review of Module 1, 2 and 3.DCP/MRP/National Filing for various EU countries.Prepare, compile, review and submit high quality submissions for all required post- approval activities in accordance with EU legislation. 2.Prepare, compile & review Regulatory/Quality documents to support submissions to various markets such as EMEA, NA, APAC, LATAM and Canada. 3.Prioritize, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress. 4.Working on software\'s like Salesforce, Raw Material Questionnaire (RMQ), Concerto, TRU database, Product development, PCPC, RIMS and PubChem. Create and/or revised Raw material and packaging specification using client Tru System and updating Raw material specifications for various attributes (Grade, Origin, Mfg Sites). 6.Manufacturers/sites to understand the change, impact assessment, implementation strategy and required documentation to meet the regulatory requirements of packaging components and Raw materials. 7.Having good knowledge of DMF, ASMF, MAA, NDA, INDA, ANDA and e CTD, CTD. 8.Well versed with EU variations Type 1A, Type 1B, Type II and line extension and US variations like AR, CBE-0, CBE-30 and PAS. 9.Well versed with SmPC, eXVMPD, article 57, CTIS, PIL, PDS, FPP and renewals and aslo event creation and submission, life cycle management.

Experience

1. Regulatory Operations Assistance Ii

   Fortrea

   Sep 2024 — Present · Pune, IN

Education

• Rajesh Bhaiyya Tope College of B. Pharmacy Aurangabad

  B. Pharmacy

  2016 — 2020

• Government college of pharmacy Aurangabad

  M. Pharmacy

  2020 — 2022