Varaprasad Shivakoti
Hyderabad
Summary
I aim to build a fulfilling career where I can leverage my talents, contribute to organizational growth, and continuously improve through dedication and dynamic engagement. About 10 years of experience in Regulatory Affairs professional with knowledge in, preparation, review, and submission of registration document/dossier for registration in India, and International markets US, HC, EU, China, and ROW countries based on CTD\ACTD format and as per country-specific requirements, Key knowledge areas are as follows; Preparation of dossiers for Pharmaceuticals and Medicinal products for India and International markets. Registration of Pharmaceuticals in India & International markets (ASEAN, EU, US) Good knowledge of US, PMDA,HC,FDA and Europe CMC-eCTD Dossier preparation & submission. Good knowledge of Good Manufacturing Practice (cGMP) & QMS Well-versed with ICH Quality guidelines, e-CTD, CTD, ACTD, NEES, and formats.
Overview
9
9
years of professional experience
10
10
years of post-secondary education
1
1
Certification
4
4
Languages
Work History
Senior Specialist - Regulatory Affairs
CURIA India Pvt Ltd (Global Shared Services)
11.2021 - Current
- Maintaining the global US,HC,CH and EU DMF gateway submissions and CMC review
- Maintaining Track-wise digital database and LOA and Annual Report (US &CEP) management
- Developing and training the Regulatory intelligence updates for the global sites.
Asst Manager- Regulatory Affairs
NECTAR LIFESCIENCES LIMITED
01.2021 - 11.2021
- Preparation, compilation & review of Dossier (CTD, ACTD & Country Specific Format) for European, CIS, Latin American, ASEAN Member States, African, GCC, Asia Countries
- Provide responses to regulatory agencies for deficiencies and comments
- ASIA: Sri-Lanka, Afghanistan, Nepal, Bhutan
- Design of specification of API, finished product, selection of analytical method based on DMF/ monographs
- To prepare PDR, Artwork, Leaflet and Specification for New Formulation (ANDA) as per requirement
- Maintenance of ANDA and API DMF life cycle management
- CEP Dossier Life cycle management.
Sr.Executive- Regulatory Affairs
Nakoda Chemicals Ltd (USFDA,TGA & MFDS facility)
12.2018 - 12.2020
- Compilation, review, and submission of Variations to CEPs in line with variation guidelines
- Provide responses to regulatory agencies for deficiencies and comments
- Handling of queries received from regulatory agencies and from customers
- Design of specification of API, finished product, selection of analytical method based on DMF/ monographs
- Keeping up to date with changes in regulatory legislation and guidelines
- Preparation / Review of various pharmacological, pre-clinical & toxicological data based on published literature
- Core dossier compilation and submission along with supporting documents/data to HA
- Review of Elemental impurity Declarations as per ICH Q3D for the Drug products and API's
- Review of Residual Solvent Declarations for Drug products and API's
- Review of Specifications and Standard Test Procedures for Drug Excipient, Drug Substances, Drug Products in compliance with Pharmacopoeias, ICH guidelines, Regulatory requirements and Regulatory queries.
Executive- Regulatory Affairs
AIZANT DRUGS & Research PVT LTD
02.2017 - 11.2018
- Preparation, Review and Compilation of ANDA's in eCTD format to USFDA and ensuring timely submission
- Active participation of the Query Responses related to the Chemistry & Manufacturing for filing of amendments to the under-review products
- Supplemental Applications: Review and compilation of Supplemental Application Related to Chemistry and Manufacturing changes i.e
- CBE-0 and CBE-30 and Prior approval supplements
- Identify, review, and approve the required documents received towards dossier compilation including
- Ensuring regulatory compliances of DMFs in connection with product applications like ANDA's
- Works closely with Cross Functional Teams and relevant Line Functions for timely delivery of overall registration dossier as per regulatory requirements, for assigned projects to meet the regulatory milestones/deliverables
- Preliminary Review of Documents (as per Regulatory eCTD standards), Build submissions, Compilation, QC Review (Quality Checking) of all Submissions
- Compilation of product registration application Dossier to US.
Clinical Regulatory Executive
Axis Clinicals India Pvt Ltd
02.2015 - 01.2017
Education
Pharmaceutical Management & Regulatory Affairs -
Jawaharlal Technological University, Hyderabad (Nova College of Pharmacy)
04.2012 - 05.2014
Bachelor in pharmacy - undefined
Jawaharlal Technological University, Hyderabad (SSCP)
01.2007 - 05.2011
Intermediate (Bi.P,C) - undefined
Board of Intermediate Education
01.2005 - 05.2007
undefined
S.S.C Board of Secondary Education
01.2004 - 05.2005
Skills
Lifecycle Management and eCTD publishing
Life Cycle Management of Annual Reports, Variations, Renewals, Safety reports
Evaluation of change controls for post-approval changes (PAC)
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness or compliance with regulatory standards
Publishing of CEP and DMF in eCTD/NeeS/PDF as per guidelines
Optimization of documents, creation of TOC, PDF scaling, Bookmarking, Hyper-linking (create/import/export), PDF version and other activities using ISI toolbox
Word to PDF rendering of documents
Performing QC Checks using eCTD viewer
Hands on experience on eCTD document preparation, building structure, compilation, life Cycle of documents and publishing using tools
Publishing tools
eCTD (Fryer SUBMIT Pro, Extedo, Lorenz& Pharma READY) Compilation
ISI publisher,ISI tool box, MS projects
MS-Office, LORENZ eValidator, SPL Labeling (PIL) Publishing tools
Lifecycle Management and eCTD publishing
Used Microsoft Excel to develop inventory tracking spreadsheets
ECTD
Trackwise
RIMS-PRT
MS office
MS Projects
Certification
Six Sigma green belt
Personal Information
- Date of Birth: 05/04/90
- Gender: Male
- Marital Status: Married
Timeline
Senior Specialist - Regulatory Affairs
CURIA India Pvt Ltd (Global Shared Services)
11.2021 - Current
Asst Manager- Regulatory Affairs
NECTAR LIFESCIENCES LIMITED
01.2021 - 11.2021
Sr.Executive- Regulatory Affairs
Nakoda Chemicals Ltd (USFDA,TGA & MFDS facility)
12.2018 - 12.2020
Executive- Regulatory Affairs
AIZANT DRUGS & Research PVT LTD
02.2017 - 11.2018
Clinical Regulatory Executive
Axis Clinicals India Pvt Ltd
02.2015 - 01.2017
Pharmaceutical Management & Regulatory Affairs -
Jawaharlal Technological University, Hyderabad (Nova College of Pharmacy)
04.2012 - 05.2014
Bachelor in pharmacy - undefined
Jawaharlal Technological University, Hyderabad (SSCP)
01.2007 - 05.2011
Intermediate (Bi.P,C) - undefined
Board of Intermediate Education
01.2005 - 05.2007
undefined
S.S.C Board of Secondary Education
01.2004 - 05.2005