Summary

Overview

Work History

Education

Skills

Timeline

Karan Solanki

Senior Specialist, Regulatory Affairs

Mumbai

Summary

I am a process-oriented and results-driven professional with 11.6 years of experience in Regulatory operations, RIMS (XEVMPD), Medical Devices, People Management.

Overview

years of professional experience

Work History

Senior Specialist

Baxter

04.2021 - Current

Submission publishing of fully electronic submissions which include original IND/NDA/MAAs/NDS
and life-cycle sequences such as Annual Reports, Amendments, Variations, Baseline, Core packages,
Renewals, OPDP, Response to Questions, RFIs, Annual Reports, DMF, ASMF as well as Clinical
Study Reports to various Agencies (Globally) with the help of eCTDXpress and RIM Vault.
Authoring module 1 especially Authoring cover letters, electronic application forms and coordinating
the provision of translated documentation and fee payments. Ultimately compiling submission ready
variation packages necessary for mutual recognition procedure, work sharing procedure and national
submissions
Published NeeS submission for EEMEA regions, CH eDok and EU Veterinary (VNeeS) submission
and Validation.
Dispatching submission to Authority for various countries such US, Canada, Europe and UK
(CESP, EMA, UK-MHRA) for Single, Grouping and Work-sharing submission mode.
Provided support for Medical Devices as a Regulatory Coordinator. Collaborated with crossfunctional
teams to gather and organize documents according to the requirements of various
countries, and provided them to regulatory personnel for further submission
Experience in Vault RIM (Create Event, Regulatory objective, Submission Record, Content Plan
Management and Archiving).
Knowledge of ISO 13485 and EU MDR regulations.
Managed the team to perform within deadlines and goals and troubleshooting any submission issues.
Prepared a dashboard in Excel for the management to control quality and utilization within team.

Assistance Manager, Submission Publisher

Genpact

11.2016 - 04.2021

Submission publishing of fully electronic submissions which include original IND/NDA/MAAs/NDS
and life-cycle sequences such as Annual Reports, Amendments, Variations, Baseline, Core packages,
Renewals, OPDP, Response to Questions, RFIs, Annual Reports, DMF, ASMF as well as Clinical
Study Reports to various Agencies with the help of Lorenz Docubridge and EXTEDO (eCTDmanager).
Compilation and Publishing of CTA/IMPD and Core package and NeeS submission for EEMEA
regions and Paper Submission for Morocco regions.
Post-publishing activities (Upload to DEx and Archival in eDocs)
Provide technical expertise and perform activities related to submission documentation, including MS
Word document formatting, PDF processing, managing hyperlinks and bookmarks. Performing
quality check and validating compiled submissions, and finalizing submission by required dispatch
date
Reviewing documents for e-submission-readiness and conformity to FDA regulations and guidelines.
Conversion old Notice to Applicants (NtA) style dossiers to the Common Technical Document
(CTD) format.
Managed the team to perform within deadlines and goals and troubleshooting any submission
issues.
Maintaining various trackers such as Daily tracker, QC tracker and IT issues tracker.
Conducted interview and provided successful training programs to the new employees, attended
training session regarding process and performed departmental activities as per requirement

Medical Writing Document Specialist

Quintiles IMS, India

05.2016 - 11.2016

Pre-publishing like Preparing PDF source documents including intra documents hyperlinks and bookmarks, page rotation and PDF optimization.
Formatted documents and prepared e-submission readiness in compliance with ICH guidelines and regional health authorities.
Actively gathering appendices for Clinical Study Report in accordance with ICH guidelines and Delivering the QC review and appendix collections in the given time frame.
Provided support in the collection of service metrics as per the need.

Regulatory Publisher

Tata Consultancy Services)

07.2012 - 04.2016

Provide technical support on publishing software/tools and processes for the production and oversight of Regulatory documents intended for regulatory submissions.
Perform electronic publishing activities including assign source documents to electronic publishing outlines.
Works closely with subject matter experts to support authoring and formatting of submission documents, including the tracking, preparation, and finalization of Clinical Study Reports, to aid in the development and production of high-quality submissions in compliance with regulatory submission requirements and standards.
Conducted meetings for project related update and also organized staff meetings.

Education

Bachelor of Pharmacy -

Indira College of Pharmacy

Pune

04.2001 -

Skills

Life Cycle Management (eCTD /NeeS submissions)

Submission Gateways: ESG, CESP, MHRA portal &
EMA/Syncplicity portal

EU M1 Authoring

Medical Devices Co-ordinator (ISO 13485 and EU MDR regulations)

Project Management

Teamwork and Collaboration

Process Improvement

Time Management

Data Analysis - Tableau & Excel

Tools: RIM Vault, eCTDXpress, Lorenz Docubridge , EXTEDO eCTDmanager, Lorenz eValidator