Shamali Khamkar
Regulatory Affairs | Vault RIM | eCTD | CTD | Lorenz e-validator | Publishing tool | eCTD express |Submission Publishing | Promotional Submission| Review, Compilation & validation| hyperlinking| adobe acrobat| Dispatch.
- Role
- Drug Regulatory Affairs Associate at Tata Consultancy Services
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Shamali Khamkar
Upbeat customer service professional having total experience of 4.8 year as Senior ProcessAssociate. Well-spoken and friendly with excellent practical problem-solving and meticulousskills. Experienced in Regulatory Affairs | Veeva Vault | eCTD | CTD | Lorenz e-validator |synthetic molecule and bio- molecule. Publishing tool eCTD express |Submission Publishing |Promotional Submission| Review, Compilation & vaIidation| hyperIinking| adobe acrobat|Dispatch. Seeking for responsible and challenging opportunity that will utilize and enhancemy skill where I can actively devote my abilities thought dedicated challenging work.
Experience
Drug Regulatory Affairs Associate
Mar 2022 — Present · Mumbai, IN
Experience of publishing, compilation and validation of eCTD dossier for US market. Collate, compile and validate high quality CTD and eCTD section formodule M1, M2, M3, M4 and M5. Expertise in handling tools Angel CARA, eCTDexpress, CTD - publisher tool, Veeva Vault, Lorenz eValidator, Vault RIM.Publishing of promotional labelling advertising submission(PRA) including pre-regulatory submission for NDA and BLA application of two center i.e CDER and CBER.FDA submission via USFDA ESG gateway i.e IND, NDA, BLA. EU submission via CESP gateway submission, EMA gateway and non CESP submission i.e CP,NP,DCP & MRP. Having knowledge of GCC country submission and there guidelines, Virtual document(VDOC) in clinical trial application(CTA), pediatrics submission(PIP), Hyperlinking.Dispatch activities for gateway submission, eCTD, Non-eCTD, Vdoc, Nees, AU, US, EU and ROW market.proficient in dispatch activity through different type of dispatch format like CD/DVD, Paper, gateway(US, EU), electronic, box submission, GCC, Canada and ROW market as per requirement.Performing complex NAP (National application Procedure) submission for multiple countries of EU region (from 2 to 28 Countries) via CESP.Well versed in creation of delivery file for EMA submission in XML backbone as per assigned request (i.e Var Typ I, II, IAIN, PAM, PSUR, PIP) and for CESP submission (NP, DCP and MRP).
Education
SAHYADRI SHIKSHAN SANSTHAS GOVINDRAO NIKAM COLLEGE OF PHARMACY, SAWARDE, RATNAGIRI
B. Pharmacy
2014 — 2018
Savitribai Phule Pune University
Master's degree
2018 — 2020
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