R O E
Resume:
R e g u l a t o r y A f f a i r s
Sudhakar Rao Punugupati
C ONTACT
(+91)
*************@*****.***
MIG, Mayuri Nagar,
Hyderabad, Telangana, India
500049
E DUCATION
B-Pharmacy 2000-2004
Mpharmacy -2008-2009
MBA
K E Y S K I L L S
Microsoft Office
English, Hindi & Telugu
Web and tech-savvy
Typing speed of 70 WPM
Problem solving
P R O F I L E
A Regulatory Affairs professional with more than 10 years of experience in initial filing and life cycle management activities such as compilation, preparation, review, and change control assessment of the products for the CA Market. Looking to leverage my knowledge and experience into a role as suitable position.
P R O F E S S I ONAL E X P E R I E NCE
August 2012– Present -Regulatory Affairs
S e n i o r S c i e n t i s t - A u r o b i n d o P h a r m a L i m i t e d, H y d e r a b a d, I n d i a .
Preparation, review, and compilation of ANDS (solid, Injectables and Ophthalmic dosage forms) for CANADA Market.
Complete responsibilities from initial filing to final ANDS approval and manage regulatory activities for all the Injectable, Ophthalmic products and solid orals.
Plan, track, and submit Original Filings, Variations, Renewals, and Annual notifications within the stipulated time. Review dossiers in line with current regulatory requirements.
Review technology transfer documents, PDR, Drug Product and substance specifications, protocols of stability studies, reconstitution, and dilution compatibility studies to ensure the current regulatory requirements.
Review & assess Change controls through Caliber, Metric Stream and EPIQ, new product assessments and artworks (in-line with CRPs) in regulatory aspect.
Coordination with all supporting departments like FRD, FARD, QA, QC, Packaging Development, SCM and Production for planning & and compilation of regulatory submissions in stipulated timelines.
Prepare and maintain the trackers up to date.
R e g u l a t o r y A f f a i r s
Sudhakar Rao Punugupati
Team leadership
Based on the experience on different types of queries, prepare the CMC documents and minimize the anticipated query.
Junior Manager-Dr Reddys Laboratories, Hyderabad, India- December 2010 to February 2012 -FR&D
&
ResearchAssociate- Aptuit Laurus Ltd, Hyderabad, India July 2007 to November 2010 -FR&D
Literature, patent, prior art search, preformulation and ICH compliant stability studies.
Innovator product identification, procurement, and characterization.
Preparation of documents like Product Development Report (PDR), Master Formula Record (MFR), Process Optimization Report and Stability Study Report etc.
Product characterization and perform formulation strategies.
Evaluating of alternate vendors for inactive and raw materials, also formula stability studies and data interpretations as per ICH guidelines for the same.
Developed, scaled up, technology transferred IR tablet for Regulatory Markets.
Monitoring, Documenting and Troubleshooting of Scale Up, Pre-Exhibit and Exhibit Batches for Regulatory Markets.
Process Optimization and Commercial Validation.
Handling of different formulation Equipment.
Contact this candidate