Hi, I’m
RAVICHAND KONDABOLU
Regulatory Affairs
Hyderabad,
Summary
Successful 12 years of experience in Global Label Management (CCDS, SPC, USPI and ROW/PSUR, DSUR, RMP, IB).
Overview
12
years of professional experience
5
years of post-secondary education
3
Certifications
Work History
Novo Nordisk
GRL-Global Regulatory Lead & EU Affiliate (LOC)
08.2022 - Current
Job overview
- Life Cycle Management (LCM) of the product
- Submission of regulatory files, response to health authorities for EU, PIP Modification, Deregistration/Discontinuation, Drug Shortage, GPT handling
- Maintenance of marketing authorizations worldwide
- Handle change requests (LCA) for all countries
- Periodic Safety Update Reports (PSUR), Risk Management Plan (RMP), renewals, post approval changes
GlaxoSmithKline (GSK)
Country Labelling
10.2018 - 08.2022
Job overview
- Project Lead for Extended Europe (EE), Handling LOC activities for all 11 EU and 5 Non-EU countries
- Compiling, creating, and updating labels for markets UK, Ireland, Canada, Switzerland, Sri lanka, East Africa, Philippines… as per Market Specific Requirement (MSR)Supporting Local Operating Company (LOC) in creating Submissions package
- Country lead for UK/IE, Switzerland, Philippines, Cyprus and Malta
- SME for Regulatory Operations Model Labelling (ROM)
- Country Label Differences (CLD)
- Management of GRA Labelling data in regulatory systems such as: Vault, PRION and IMMS.
Pfizer
Labeling Operations Management (LOM)
07.2016 - 10.2018
Job overview
- Updating CCDS, CCSI, SmPC, USPI, PI, IFU and EU Outer label
- Providing support through the guidance and direction from the Global Labeling Lead (GLL)
- Ensuring the label quality and consistency including the formatting and editing as per the supporting document
- Utilizes the PfLEET2 system to assist with managing and tracking labeling projects
- Utilizes the Global Document Management System (GDMS) tool to upload, edit and obtain approval of labeling documents when applicable
- Combine requests or projects or create multiple projects from one or more requests as necessary to facilitate the labeling review process, under the direction of the GLL.
FREYR SOFTWARE SERVICES LTD
Global Labeling Management (GLM)
05.2014 - 05.2016
Job overview
- Creating and updating of Core Data Sheet
- Involving in Safety review meetings and determining what to include and exclude in CDS
- Drafting and Formatting CDS to satisfy international regulatory agencies and end-users
- Sending notification to Local Operating Company (LOC) regarding Core Data Sheet changes for Local Product Document (LPD) update
- Tracking changes made to SmPC's by Local Market through Master Implementation Trackers on timely basis and same into the system tool (PSMF)
- Responsible to ensure LOC's timely submission to HA and implementation into local labels
- Generation of Compliance monthly reports or PSMF Metrics.
GVK BIOSCIENCES
Research Chemist
05.2012 - 12.2013
Job overview
- To develop and validate bio-analytical method using biological matrices (plasma)
- Perform bulk spiking
- Analyzing study samples
- Perform repeat analysis, and incurred sample analysis
- Documenting all process related data online as per regulatory compliance.
Education
Greenwich UniversityKent, UK
MSc. Pharmaceutical Sciences
10.2009 - 01.2011
JNTUHyderabad
Bachelor's in Pharmacy
05.2005 - 05.2009
Skills
Mentoring
undefinedCertification
Regulatory Affairs Certificate (RAC)
Timeline
Regulatory Affairs Certificate (RAC)
08-2022
GRL-Global Regulatory Lead & EU Affiliate (LOC)
Novo Nordisk
08.2022 - Current
Six Sigma Green Belt
10-2018
Country Labelling
GlaxoSmithKline (GSK)
10.2018 - 08.2022
Labeling Operations Management (LOM)
Pfizer
07.2016 - 10.2018
Global Labeling Management (GLM)
FREYR SOFTWARE SERVICES LTD
05.2014 - 05.2016
Research Chemist
GVK BIOSCIENCES
05.2012 - 12.2013
Greenwich University
MSc. Pharmaceutical Sciences
10.2009 - 01.2011
Registered Pharmacist in Pharmacy council of India (P.C.I) (Since 2009).
09-2009
JNTU
Bachelor's in Pharmacy
05.2005 - 05.2009
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