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Suresh Kumar P Email & Phone Number
DGM - Global Regulatory Affairs
at
AUROBINDO PHARMA LTD
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✓ Verified Jun 2026
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Profile completeness 86%
Current company
Role
DGM - Global Regulatory Affairs
Location
Hyderabad, Telangana, India
Who is Suresh Kumar P? Overview
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Quick answer
Suresh Kumar P is listed as DGM - Global Regulatory Affairs at AUROBINDO PHARMA LTD, based in Hyderabad, Telangana, India. AeroLeads shows a matched LinkedIn profile for Suresh Kumar P.
Suresh Kumar P previously worked as AGM - Global Regulatory Affairs at Aurobindo Pharma Ltd and Manager - Global Regulatory Affairs at Dr. Reddy'S Laboratories. Suresh Kumar P holds M.Sc., Chemistry from Acharya Nagarjuna University.
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AUROBINDO PHARMA LTD
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Profile bio
About Suresh Kumar P
Drug Regulatory Affairs Professional with over 20 years of experience with continuous advancement.
Current workplace
Suresh Kumar P's current company
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Aurobindo Pharma Ltd
Website
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10 roles
Suresh Kumar P work experience
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Dgm - Global Regulatory Affairs
Agm - Global Regulatory Affairs
May 2021 - Mar 2024
Manager - Global Regulatory Affairs
Sep 2014 - May 2021
Sr. Manager - Global Regulatory Affairs
Global Regulatory Submissions.Handled a team of CMC post approval life cycle submissions for a multinational pharmacetuical companies - Drug Product Renewal, Annual Updates, Amendments, Variations - across all countries.
Sep 2012 - Sep 2014
Assoc Manager Ii
Prepared / Authored submissions for small molecules, marketed products (Drug Product Dossiers / DMFs). Handled several submissions for drug product registrations, including CMC dossier writing for new submissions and post approval variations. Regulatory affairs CMC expertise in CTAs/ IND/ IMPDs/ NDA/ MAA / DMF for all markets (EU/ US / ROW) and their.
Jan 2007 - Jul 2012
Regulatory Affairs Executive
Aurobindo Pharma
- Successful in filing several API / DS intemediates DMFs (sterile and non-sterile APIs) to US FDA- Successful in filing Certificate of Suitability with EDQM and contributed significantly in getting faster approvals.- Successful in filing several DMFs (Open & Closed part's) to regulatory authorities in Europe, Canada, Korea and DMFs in most of the.
Jul 2004 - Jan 2007
Regulatory Affairs
Global Calcium
Responsible for Review, Preparation, Customization and Submission of Drug Master Files (DMFs) [CTD] to EDQM.Data collection and Review of documents required for DMF/CTD preparations (viz. Analytical Reports, Process Validation Reports and BMR/BPRs, Protocols).Involving in QA activities such as preparation of SOP’s, BMR and Site Master Files.Worked with R&D.
Jul 2003 - Jul 2004
Regulatory Affairs
Export country, new product registration, including preparation / customization of dossier, submission, correspondence and follow-up and also coordinating export country registration in different South East Asian countries including Nepal, Bangladesh and CIS countries and also provided free product samples for the same.Responsible for maintaining all.
Jan 2001 - Jul 2003
Chemist
Preparation of Master Product Manuals, In-process records, Specifications (In-process, Finished products & Raw Material) for various pharmaceutical dosage forms. Preparation of licensing information (label/carton/leaflets information & composition details etc.) for submitting to regulatory authorities for various pharmaceutical dosage forms & Developed.
Nov 1998 - Dec 2000
2 education records
Suresh Kumar P education
M.Sc., Chemistry
B.Sc., Chemistry, Industrial Chemistry, Mathematics
FAQ
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Quick answers generated from the profile data available on this page.
What company does Suresh Kumar P work for?
Suresh Kumar P works for AUROBINDO PHARMA LTD.
What is Suresh Kumar P's role at AUROBINDO PHARMA LTD?
Suresh Kumar P is listed as DGM - Global Regulatory Affairs at AUROBINDO PHARMA LTD.
Where is Suresh Kumar P based?
Suresh Kumar P is based in Hyderabad, Telangana, India while working with AUROBINDO PHARMA LTD.
What companies has Suresh Kumar P worked for?
Suresh Kumar P has worked for Aurobindo Pharma Ltd, Dr. Reddy'S Laboratories, Makrocare, Novartis, and Aurobindo Pharma.
How can I contact Suresh Kumar P?
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What schools did Suresh Kumar P attend?
Suresh Kumar P holds M.Sc., Chemistry from Acharya Nagarjuna University.
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