Trushnali Pawar
Junior Regulatory Affairs Specialist | NIPER-M | SPPU
- Role
- Junior Regulatory Affairs Specialist at Labcorp
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Trushnali Pawar
I completed, B.Pharmacy from \"Savitribai Phule Pune University\" and M.S.(Pharm.) in Medicinal Chemistry from \"NIPER, S.A.S.Nagar, Mohali, Punjab\".and also completed \"PGD Course in Regulatory Affairs [API & Formulation]\" from \"Institute of Pharmaceutical Management [IPM]- an Autonomous Training Institute, Mumbai\".Interested inRegulatory Affairs. Drug Regulatory Affairs [API & Formulation].• ICH Quality Guidelines Q1, Q2, Q3 & Q6 and Q11.• Drug Master Files (CTD, eCTD). • Dossier (CTD, ACTD, eCTD, NeeS, PDF).• DMF & Dossier Preparation. • ANDA, MAP, CEP, ASMF, USDMF. • Handling Deficiencies. • Selection of Starting Materials. • Review of DMF and Dossiers.
Experience
Junior Regulatory Affairs Specialist
May 2022 — Present · Pune, IN
Actively working on End to End Project (E2E)- Creation, Remediation/Revision of Finished Good specifications and all Bill of Material specification (Formula device, Product release, Raw materials, Packaging components, Decorated components) using SAP, EtQ symphony & TRU system.2. Worked on the Product Development portal- identifying & reviewing discrepancies & updating the formulae for finished products.(NA,LATAM,EMEA,APAC)3. Process training indepth & co-ordination of the junior staff members.4. Worked on various Ad-hoc Projects with stringent deadline.5. Handling Client meeting for regions-EMEA, NA, LATAM, APAC
Education
Institute of Pharmaceutical Management [IPM] - an Autonomous Training Institute ... at IPM, Mumbai
Post Graduate Diploma, Regulatory Affairs [API & Formulation]
Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm, B.Pharmacy
2014 — 2018
National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali
M.S.Medicinal Chemistry, Medicinal and Pharmaceutical Chemistry
2018 — 2020
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