Applications related to (Microsoft office tools): MS Word, MS Excel, MS Power point
Saritha Naramsetty
Senior Regulatory Operations Specialist II
Bangalore,KA
Summary
Saritha Naramsetty is a Senior Regulatory Operations Specialist II with over Eleven years of experience in Regulatory Operations. Mrs. Naramsetty holds a Master of Pharmacy.
Overview
11
11
years of professional experience
2013
2013
years of post-secondary education
1
1
Certification
4
4
Languages
Work History
Senior Regulatory Operations Specialist II
MMS
02.2018 - Current
- Proficient with maintaining regulatory tracking and archiving submissions in document management systems; provides mentorship for others
- Proficient with publishing regulatory documents and submissions according to ICH eCTD format, submission ready standards and client style guides; provides mentorship to others
- Proficient with preparing and compiling documents for submission to regulatory health authorities; provides mentorship to others
- Proficient with quality control checks to documents and regulatory submissions to ensure compliance with ICH and MMS and client standards; provides mentorship to others
- Proficiency with MS Office and Adobe Acrobat Professional, ToolBox, eCTD publishing tool, SAS Viewer, eCTD Viewer and WebTrader/ ex-US portals; provides mentorship for others
- Proficient understanding of the eCTD structure and the structure and content of clinical study reports
- Proficient coordination with clinical CROs, local Authorized Agents and third-party vendors on regulatory submissions
- Independently or with support from LM as needed: Maintains submission project plan and tracks components; Manages project risks and timeline; Manages multiple projects simultaneously
- Maintains a strong understanding of applicable regulations and ICH and health authority guidance as they pertain to document management and Regulatory Operations; Mentors others regarding regulations and guidance; Advises on necessary updates regarding regulations and guidance
- Experienced in scheduling/conducting Interactive Team meetings
Regulatory Associate
PAREXEL International
10.2013 - 01.2018
- Performed Pre publishing activities including Bookmarking, Hyperlinking
- Worked on creating new registrations for the newly approved dosage forms and in data migration using eRIMS for many INDs, NDAs, ANDAs, MAAs
- Worked on Transfer of Module 3 Data or writing of Module 3 Documents according to client specifications using First doc
- Worked on short deadline tasks like Module 2 document transfer using First doc, creating suitable citations, processing reference documents into RCAM (Regulatory Content Authoring and Management system)
- Performed Quality control checks to ensure the high quality of submission
Education
M. Pharmacy -
Rajiv Gandhi University of Health Sciences
Bangalore, KarnatakaB. Pharmacy - undefined
Rajiv Gandhi University of Health Sciences
Bangalore, KarnatakaSkills
Microsoft Office
Adobe
Insight Publisher
ARIS Register
ISI toolbox
Smart Desk for PDF and Word
Lorenz eValidator
DocuBridge Suite for Publishing
ROSETTA Phoenix eCTD Viewer R42
VEEVA Vault
Beyond Compare
Nuance compare
Certification
Advanced Certificate in Clinical Research (ACCR), Catalyst Clinical Services Pvt. Ltd, New Delhi, New Delhi
Affiliations
Andhra Pradesh State Pharmacy Council, Registered Pharmacist
Publications
Vigna mungo Mucilage - A Natural polymer in the design of matrix-based sustained release tablet of aceclofenac., International Journal of Pharmaceutics Review and Research (IJPRR), 05/01/13
Degree
M Pharm
Accomplishments
1) Received appreciation over the years for Exhibiting ‘SOUL– Sense Of Urgency and Leadership’.
2) Received appreciation from project manager in Liquent – A PAREXEL Company, Bangalore for exhibiting Parexel High Performance corporate values: ‘I delight customer’, ‘Client service and Quality’, ‘Team Work’, I Say What I Think.
Listed asthe meritorious studentin college magazine for standing college first and University 8th Rank in RGUHS during thetenure of M. Pharmacy
Additional Information
· Advanced Certificate in Clinical Research (ACCR) from Catalyst Clinical Services Pvt. Ltd, NewDelhi.
· International English Language Testing System (IELTS) : overall band score of 6.5
Listening: 6.0; Reading: 5.5; Writing:6.5; Speaking: 7.5
Software
Interests
Listening to Music, Gardening, Cooking
Timeline
Senior Regulatory Operations Specialist II
MMS
02.2018 - Current
Regulatory Associate
PAREXEL International
10.2013 - 01.2018
B. Pharmacy - undefined
Rajiv Gandhi University of Health Sciences
M. Pharmacy -
Rajiv Gandhi University of Health Sciences