Shiv Kumar Somani (Master of Pharmacy)

RESUME + (91) 7874588220, sksomani88@gmail.com, LinkedIn: https://www.linkedin.com/in/shivsomani

CARRIER OBJECTIVE;

To work for a company that offers me a stable and positive atmosphere, this will be an inspiration to
develop my personal and professional skills in order to contribute meaningfully to my employer.
PROFILE SUMMARY;

M. Pharmacy in Pharmaceutical Management & Regulatory Affairs with 4 years of experience in

Regulatory Publishing.
Handled compilation, verification, and validation and life-cycle management of eCTD/NeeS dossier.
Transfer Labeler, ER, NDC and Product information (COL, PDP and DLD) into SPL R4 XML format.
Expert in handling publishing tools i.e. Toolbox, eCTD software, eCTD Viewer, eValidator and Gateway.
EMPLOYMENTS AND WORK EXPERIENCE;

Company Designation Period Job Profile

Amneal Pharmaceuticals Senior Executive May, 2016 - Present
Hospira, a Pfizer Company Executive May, 2015 to April, 2016 Refer
Sarjen Systems Pvt. Ltd. Executive July, 2013 April, 2015 Overall Job Profile

ACADEMIC QUALIFICATION;

Qualification University/Board Year of Passing % Marks

M. Pharmacy RUHS, Jaipur (Rajasthan) 2013 65.64%
B. Pharmacy RUHS, Jaipur (Rajasthan) 2010 64.33%
12th Standard RBSE, Ajmer (Rajasthan) 2006 54.15%
10th Standard RBSE, Ajmer (Rajasthan) 2003 53.14%
AWARDS AND ACHIEVEMENTS;

Postgraduate scholarship by AICTE (GPAT- qualified).

Awarded as Team of Month in January, 2016 at Hospira, a Pfizer company.
Awarded for significant support for SPL (DLD update and review) activities.
Successfully organized WebEx Webinar on Regulatory Updates, 2015 and Standard PDF Properties
Specification at Sarjen Systems.
Compile and validate number of original ANDA dossier for US region within given time frame, before
the new stability guideline came into the force (from 20th, June 2014).
PERSONAL VITAE;

Father Name : Ram Prakash Somani

Date of Birth : July 10, 1986
Marital : Married
Linguistic Proficiency : Hindi, English, Guajarati and Rajasthani
REFERENCES DECLARATION;

I vouch the authenticity of above furnished facts. If given an opportunity to serve, I assure that my
performance would be whole hearted.
Place: Ahmedabad
Date: August 6, 2017 SHIV KUMAR SOMANI
 Submission schedule tracker
Regulatory publishing strategy
eCTD uploading checklist/tracker
Up to date with new regulatory requirements
Submission
Management

Drug listing
Establishment
Acrobat professional
registration
Document ISI toolbox/writer
NDC labeler code Structured
Level MD5 checker
GDUFA self Product
Publshing PDF specifications
identification Labeling (SPL)
(DLP) Nees/CTD format
DLD analyst
SPL Xforms
Pragmatic validator

Job
eCTD software
Description (eCTDXPress and
KnowledgeNET)
eCTD Viewer
(Rosetta and
Submission eCTDOffice)
Level eValidator (Lorenz
Troubleshooting
Publishing and Extedo EURS)
(SLP) eCTD checklist
Life-cycle
Management
Quality check
Co-ordination with IT department
Submission
Co-ordination with vendor and/or client
Dispatch and
Expertise in eCTD validation criteria ESG gateway
Archival
Expertise in XML (manual knowledge) Physical media (CD, DVD)
Dossier repository
RIMS