S. R. Naresh Kumar Email & Phone Number

Bengaluru, Karnataka, India

- Working as Veeva RIM business admin and helps in resolving the RIM and submission publishing issues with respect to compilation, content plan, archive by closely interacting with Veeva team for complex issue.- Transforming the business requirements to development by collaborating with technical team after taking necessary approval from business. Testing of newly developed features as per business requirements in testing environment and suggesting the improvements. - Resolving the incidents in service Now, IT4U and handling activities like creation of Clinical and nonclinical studies, packaging, manufacturers, change control, deletion of records, preparation of Veeva reports.- By providing regular different health authority updates and suggesting the implementation of latest DTD versions in RIM.

Bengaluru, Karnataka, India

- Expertise in doing RIM Publishing which includes creation of application, submissions, content plan, compilation, checking of open validation results, dispatching through RIM and archiving of submissions.- Responsible for creating the submission packages in eCTD format using eCTD Xpress for regions like US, GCC, Australia, Canada, Switzerland, Brexit, and EU. Created submission packages for all types of submission types including Initial IND, BLA, baseline by collaborated with multiple teams like Regulatory Scientists, Clinical Regulatory associates, Labelling team, CMC team.- Worked in Veeva vault testing team for testing the scenarios before implementation into production of RIM publishing and also for ad-promo publishing. Worked as SME for IT issues from our team, ad-promo submissions, rim related issues.-Worked on post marketing submissions for all major regions like PSUR, DSUR, RTQ's, Labelling Amendments, Advisory comments, Annual Reports.- Experience in drafting of USFDA forms like 1571, 356h, 2252, 2253, 3674 forms and cover letters for Health Canada according to the submissions.- Expertise in doing Quality check for all types of submissions for all regions.- Experience in checking drafted forms and covers for US and HC.- Worked as a Mentor for interns, given training session for newly joined team members. Regular monitoring of team workload and allocation of work to the team members if required.- Worked with FDA and have been part of User Acceptance Testing where I have tested different types of scenarios which FDA has suggested.

Bangalore Urban, Karnataka, India

Bangalore Area, India

- Worked on submission formats like eCTD, NEES, ASEAN format, Paper submissions for different markets.- Experience in creating submission package by using software’s like Insight Publisher, eCTD Manager, ISI publisher. Publishing activities include Documents verification, assigning documents as per the requirement, publishing, doing post publishing jobs like bookmarking, hyperlinking.- Validating submission packages using Lorenz and other software's, fixing the issues if any and make sure that submissions is error free.- Experience in Regulatory Information Management System (RIMS) in STAR database (TRS tracker) in updating information. Creations of Application, submission, License, timelines updates, XEVMPD activities.- Experience in handling Documentum like Eldorado, First Doc, CARA. Worked on Document level publishing activities like creating bookmarks, Hyperlinks, setting PDF specifications as per the agency standards.- Experience in word formatting, updating of Quality documents, Conversion of documents from eCTD to ASEAN eCTD using plugins in Microsoft word. Over the span of 5 years, worked on multiple projects with global clients got an exposure in checking of requirements and working accordingly.

Bangalore Urban, Karnataka, India

Hyderabad Area, India

Proteome analysis, Genomic DNA isolation, Plasmid isolation, Transformation, PCR, cloning, mice and rat dissection, collection and processing of tissues, Immuno HIstochemistry techniques like beta catenin, alcian blue, Brdu staining, Handling microscope

I have a knowledge on handling of bioinformatics tools, Extraction of data in any data formats using PERL, C, web based designing, RI have done project in masters under the guidance of Dr. Chhabinath Mandal(Ex-Scientist), IICB, kolkata and Prof. Arunasish Acharya, School of Education and Technology Department, KolkataMolecular Docking using Discovery studio and GOLD, Pharmacophore mapping using InsightII under the guidance of Dr. Nanda Goshal

Ms. Pharm, Pharmacoinformatics, 8.86

MS.Pharmacy

Bachelor Of Pharmacy (B.Pharm.), Pharmacy, 72.3%

B.Pharmacy