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Kishor Ullewad
Regulatory Affairs Professional
Praful Nagar, Nanded Road, Bhokar
Summary
Regulatory Affairs professional with over nine years of experience, a strong work ethic, and the ability to manage multiple priorities.
Overview
9
9
years of professional experience
6
6
years of post-secondary education
4
4
Certificates
3
3
Languages
Work History
Manager - Regulatory Affairs
Pharmanovia
Vadodara
11.2019 - Current
- Supported in planning, preparation, and submission of dossiers for registration and life cycle management of branded products in EU, MENA, and APAC regions.
- Successfully completed marketing authorization transfers for 03 priority projects having diverse product portfolio with marketing authorizations across multiple markets.
- Organized meetings with different stakeholders and presented project plans to align different regulatory strategies, based on supply map and business goals.
- Managed preparation, review and finalization of various administrative, CMC, clinical, non-clinical documents.
- Supported in review, impact analysis, submissions, and implementation of several high priority changes.
- Communicated with regulatory authorities and local affiliates for timely submission and approval of applications.
- Maintenance of regulatory intelligence database in line with updated guidelines and regulations
- Handled submission publishing tools such as Veeva Vault RIM, PharmaReady, Lorenz validator.
Sr. Executive - Regulatory Affairs
FDC Limited
Mumbai
02.2019 - 11.2019
- Prepared and submitted dossiers for registration and life cycle management of generics in US, EU, and South Africa.
- Proficiently managed new registration of 02 products in South Africa and UK.
- Assessed change controls for identification of regulatory impact, and submitted appropriate post approval variations.
- Supported manager in submission of about 10 minor and 02 major variations in EU Countries.
- Reviewed respective administrative, CMC, clinical and non-clinical documents as per applicable regulatory guidelines.
- Worked on publishing and document management tools such as EDUCE, Lorenz, DMS, etc.
Associate - Regulatory Affairs
PAREXEL International Pvt. Ltd
Bangalore
03.2018 - 02.2019
- Supported clients in submitting about 15 high-priority variations across different EU and emerging markets.
- Timely updated eRIMS database in order to reflect latest registered information.
- Liaised with submission managers and local affiliates for timely submission of response to health authority queries.
- Handled document management and publishing tools such as Veeva Vault, SharePoint, and Liquent Insight.
Scientist II - Regulatory Affairs
Torrent Pharmaceuticals Ltd
Gandhinagar
08.2016 - 03.2018
- Handled preparation, review, and submission of generic products' dossiers for registration in US, EU, and APAC markets.
- Supported team in successful registration of 03 products in US and ASEAN region.
- Managed several controlled correspondence submissions to USFDA.
- Managed submissions to local authority for Import license, Test License, additional product licenses, etc.
- Completed authoring, review, and finalization of technical (CMC), administrative, clinical, non-clinical documents.
- Handled SAP, document management and publishing tools such as Lorenz Docu-bridge and DMS.
- Resolved queries and negotiated with health authority for approval of crucial changes to products.
Executive - Regulatory Affairs
Himalaya Drug Company
Bangalore
01.2015 - 08.2016
- Completed registration of about 25 healthcare products in LATAM region by submitting appropriate country specific dossiers.
- Supported team in submitting applications to local authorities for applying export certificates.
- Coordinated with relevant stakeholder for obtaining legalization of required documents in line with country specific requirements.
- Participated in review of clinical, non-clinical reports, products' composition, validation reports, specifications, stability data, etc.
- Responded to queries arising from submissions in timely manner.
- Maintained regulatory licenses and regulatory intelligence database.
- Prepared and drafted new checklists and procedures for improvement of department's performance.
Research Associate - Regulatory Affairs
Accutest Research Laboratories Pvt. Ltd
Mumbai
10.2013 - 01.2015
- Authored about 10 clinical study reports and related documents for registration of generic products in US, EU and other regulated markets.
- Supported clients in preparation of clinical, non-clinical summaries, and reports.
- Supported team in obtaining Test licenses, NOCs, and other applicable permissions from local authorities.
- Actively involved in compilation and publishing of module 5, partially module 1 and module 2 in eCTD format.
- Managed responses to queries received from clients and health authorities.
- Reviewed study specific Case Report Forms, bio-analytical method validation protocols, reports, and related data.
- Maintained and protected electronic databases.
Education
Master of Pharmacy - Pharmacology, Toxicology and Therapeutics
Bombay College of Pharmacy
Kalina, Santacruz (E), Mumbai 08.2011 - 10.2013
Bachelor of Pharmacy - Pharmaceutical Sciences
Government College of Pharmacy Karad
Satara, Mharashtra, India 08.2007 - 05.2011
Skills
Regulatory strategy
undefinedAccomplishments
- Implemented new document filing checklist and organizational procedures while working with Himalaya Drug Company.
- Played a major role in Veeva Vault RIM data migration and implementation at Pharmanovia.
- Promoted from Associate Manager to Manager at Pharmanovia.
- Awarded 'Employee Choice Star Award' by Pharmanovia for the year 2021.
Additional Information
- Qualified national level Graduate Pharmacy Aptitude Test (GPAT) in 2011.
- Qualified state level Maharashtra - Common Entrance Examination (MH-CET) in 2007.
Certification
English Certificate (C1 Advanced) received from EF Education First.
Interests
Writing
Travelling
Cooking
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Your daily life is your temple and your religion.
Kahlil Gibran
Timeline
English Certificate (C1 Advanced) received from EF Education First.
12-2022
Good Clinical Practice (GCP) Certificate received from Indian Society for Clinical Research.
07-2022
Certificate course in Intellectual property (IP), conducted by WIPO.
12-2021
Manager - Regulatory Affairs
Pharmanovia
11.2019 - Current
Sr. Executive - Regulatory Affairs
FDC Limited
02.2019 - 11.2019
Associate - Regulatory Affairs
PAREXEL International Pvt. Ltd
03.2018 - 02.2019
Scientist II - Regulatory Affairs
Torrent Pharmaceuticals Ltd
08.2016 - 03.2018
Executive - Regulatory Affairs
Himalaya Drug Company
01.2015 - 08.2016
Research Associate - Regulatory Affairs
Accutest Research Laboratories Pvt. Ltd
10.2013 - 01.2015
Master of Pharmacy - Pharmacology, Toxicology and Therapeutics
Bombay College of Pharmacy
08.2011 - 10.2013
Maharashtra State Certificate in Information Technology received from Maharashtra Knowledge Corporation Ltd.
08-2009
Bachelor of Pharmacy - Pharmaceutical Sciences
Government College of Pharmacy Karad
08.2007 - 05.2011
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