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Dr. Harshad Kothawade Email & Phone Number
Director, Head of Regulatory Management and Trade Compliance India, South East Asia, ANZ
at
Merck Group
1 work email found
@yahoo.co.in
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 86%
Current company
Role
Director, Head of Regulatory Management and Trade Compliance India, South East Asia, ANZ
Location
Mumbai, Maharashtra, India
Company size
Who is Dr. Harshad Kothawade? Overview
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Quick answer
Dr. Harshad Kothawade is listed as Director, Head of Regulatory Management and Trade Compliance India, South East Asia, ANZ at Merck Group, a with 31759 employees, based in Mumbai, Maharashtra, India. AeroLeads shows a work email signal at yahoo.co.in and a matched LinkedIn profile for Dr. Harshad Kothawade.
Dr. Harshad Kothawade previously worked as Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ at Merck Group and Head of Regulatory Management & Trade Compliance, India at Merck Group. Dr. Harshad Kothawade holds Doctor Of Philosophy - Phd, Pharmaceutical Sciences, 1St from Sri Satya Sai University Of Technology & Medical Sciences, Sehore.
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Email format at Merck Group
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*@yahoo.co.in
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Profile bio
About Dr. Harshad Kothawade
Associated with Pharmaceutical & Life Science Industry Since 2006, started as formulation development scientist & since 2007 hard core Regulatory affairs' activities.Well versed with general procedures as a part of Global Regulatory Affairs, general compliance & conduct of Multinational companies with Global Regulatory Authorities I am a proactive and achievement-oriented professional offering over 16 years of rich experience in Regulatory Compliance, Trade Compliance, and Imports & Export Operations, responding to queries, dossier, documentation, enhancing operational efficiency while reducing the cycle time.Currently associated with Merck Group as Director/ Head of Regulatory Management & Trade Compliance, Global Regulatory Affairs and Integrating the regional knowledge throughout the product lifecycle with aspects of effective management and strategy development.I am a forward thinking person with proficiency in implementing Government Affairs strategies, playing a pivotal role as the representative like IPEC, FICCI, ISPE India Affiliate, PDA India, Chemexcil, RX 360 etc., Regulations and guidance governing drugs during development and validations including post-marketing, in the US/EU, ROW & Emerging Markets, E CTD, Minitab 14, Statistica, IBM SCORE, Take Solution, RIMS VEEVA Vault, Educe, Educe SPL, InDesign Software for Actual Labeling Preparation, SAP – Global Trade Service (GTS) and paper CTD submissions including Dossier Management by Educe Solutions, IBM SCORE, ECTD Express by ISI Regulatory Solutions.
Current workplace
Dr. Harshad Kothawade's current company
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Merck Group
9 roles
Dr. Harshad Kothawade work experience
A career timeline built from the work history available for this profile.
Director, Head Of Regulatory Management & Trade Compliance India, South East Asia, Anz
Current• Playing a pivotal role as the Head of Regulatory Management & Tarde Compliance APAC • Helping in maintain an information network for monitoring domestic and international Regulatory developments, followed by appropriate preventive communication and training• Leading new regional strategic projects (Including Global/Regional implementation) within Merck Group• Provides regulatory expertise for new strategic areas and technologies as required for new product development including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements and regulatory compliance expectations during early development• Interfacing/partner with Marketing, Commercials, Manufacturing sites, Operations, Distribution, Trade Compliance, R&D, QA, QC and country Regulatory units; managing the numerous potentially cross-discipline teams of professionals and is accountable for the performance and results of the team• Spearheading the IND/NDA Submissions, ANDA Submissions, EU Submissions, DMF Submission, pre submission facility correspondence with Authorities, product lifecycle management• Managing the different eCTD Validators such as Lorenz, extedo GECCO, Take Solution, Educe Dossier Management for eCTD & SPL (Structured Product Labeling) Software for Labeling Submission as well as Document Management System (DMS) and RIMS VEEVA Vault• Spearheading the US FDA, ANVISA Inspection, ROW/Emerging Markets, EMEA Market Inspection, Review for correctness and completeness of plant and R&D documents• Ensuring the adherence towards the local custom compliance as it relates to new operations setup, business opportunities and product launches/commercialization• Providing the policy directions, advice, and guidance for import/export activities to Commercial, Product Management, Customer Excellence, Field Services, Supply Chain and Distribution• Collaborating with the custom authorities, fright forwards and customs brokers to process import and export shipments
Apr 2022 - Present
Head Of Regulatory Management & Trade Compliance, India
Playing a pivotal role as the Head of Regulatory Management & Tarde Compliance India • Helping in maintain an information network for monitoring domestic and international Regulatory developments, followed by appropriate preventive communication and training• Leading new regional strategic projects (Including Global/Regional implementation) within Merck Group• Provides regulatory expertise for new strategic areas and technologies as required for new product development including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements and regulatory compliance expectations during early development• Interfacing/partner with Marketing, Commercials, Manufacturing sites, Operations, Distribution, Trade Compliance, R&D, QA, QC and managing the numerous potentially cross-discipline teams of professionals and is accountable for the performance and results of the team• Spearheading the IND/NDA Submissions, ANDA Submissions, EU Submissions, DMF Submission, pre submission facility correspondence with Authorities, product lifecycle management• Managing the different eCTD Validators such as Lorenz, extedo GECCO, Take Solution, Educe Dossier Management for eCTD & SPL (Structured Product Labeling) Software for Labeling Submission as well as Document Management System (DMS) and RIMS VEEVA Vault• Spearheading the US FDA, ANVISA Inspection, ROW/Emerging Markets, EMEA Market Inspection, Review for correctness and completeness of plant and R&D documents• Ensuring the adherence towards the local custom compliance as it relates to new operations setup, business opportunities and product launches/commercialization• Providing the policy directions, advice, and guidance for import/export activities to Commercial, Product Management, Customer Excellence, Field Services, Supply Chain and Distribution• Collaborating with the custom authorities, fright forwards and customs brokers to process import and export shipments
Aug 2017 - Mar 2022
Head Of Regulatory Affairs
Apr 2015 - Jul 2017
Manager Regulatory Affairs
Dec 2013 - Mar 2015
Manager Drug Regulatory Affairs
• Reviewing/preparing the:Dossier for Regulated Market (US, EU, Canada, AUS, WHO-Geneva, Brazil, South Africa) and leading the eCTD Submission for Regulated Market through IBM-SCORE Software, Educe Software & Take Solution Softwareo Labeling section for ANDA’s, ANDS and MAA’s (Pack insert, Patient Information Leaflet’s, side by side comparison with RLD, Annoted text/container labeling, Structured Product Labeling (SPL), SPC etc.)• Maintaining the life cycle of submitted NDA/ANDA/MAA’s/ANDS and DMF/CEP/ASMF; submitting the annual reports, amendments (CBE 30 and PAS) and variation filings as per the timeline
Jan 2012 - Dec 2013
Manager Regulatory Affairs
Jb Chemicals & Pharmaceuticals Limited
Dossier for Regulated Market (US, EU, Canada, AUS, WHO-Geneva, Brazil, South Africa) and leading the eCTD Submission for Regulated Market through IBM-SCORE Software, Educe Software & Take Solution Softwareo Labeling section for ANDA’s, ANDS and MAA’s (Pack insert, Patient Information Leaflet’s, side by side comparison with RLD, Annoted text/container labeling, Structured Product Labeling (SPL), SPC etc.)• Maintaining the life cycle of submitted NDA/ANDA/MAA’s/ANDS and DMF/CEP/ASMF; submitting the annual reports, amendments (CBE 30 and PAS) and variation filings as per the timeline
Jul 2011 - Jan 2012
Assistant Manager Regulatory Affairs
Dossier for Regulated Market (US, EU, Canada, AUS, WHO-Geneva, Brazil, South Africa) and leading the eCTD Submission for Regulated Market through IBM-SCORE Software, Educe Software & Take Solution Softwareo Labeling section for ANDA’s, ANDS and MAA’s (Pack insert, Patient Information Leaflet’s, side by side comparison with RLD, Annoted text/container labeling, Structured Product Labeling (SPL), SPC etc.)• Maintaining the life cycle of submitted NDA/ANDA/MAA’s/ANDS and DMF/CEP/ASMF; submitting the annual reports, amendments (CBE 30 and PAS) and variation filings as per the timeline
Jul 2008 - Jul 2011
Management Trainee
Formulation Development Process developmentLean six SigmaAnalytical method devlopment
Jun 2007 - Jul 2008
Team & coworkers
Colleagues at Merck Group
Other employees you can reach at merckgroup.com. View company contacts for 31759 employees →
MR
Michelle Ricasa, Cpa
Colleague at Merck GroupPhilippines
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メ阿
メルク 阿多隼人
Colleague at Merck GroupJapan
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YQ
Yi Qu
Colleague at Merck GroupShanghai, China
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MZ
Myra Zmarsly
Colleague at Merck GroupDarmstadt, Hesse, Germany
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MR
Manuela Rojacher
Colleague at Merck GroupAustria
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NP
Noelia Pietrini
Colleague at Merck GroupArgentina
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ER
Eduard Rogalsky
Colleague at Merck GroupHainburg, Hesse, Germany
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LY
Lu Yeye
Colleague at Merck GroupChaoyang District, Beijing, China
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XL
Xincheng Liu
Colleague at Merck GroupShanghai, China
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AÇ
Anıl Çeli̇k
Colleague at Merck GroupAdapazarı Bucağı, Sakarya, Türkiye, Turkey
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Michelle Ricasa, Cpa
Colleague at Merck GroupPhilippines
View →
メ阿
メルク 阿多隼人
Colleague at Merck GroupJapan
View →
YQ
Yi Qu
Colleague at Merck GroupShanghai, China
View →
MZ
Myra Zmarsly
Colleague at Merck GroupDarmstadt, Hesse, Germany
View →
MR
Manuela Rojacher
Colleague at Merck GroupAustria
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NP
Noelia Pietrini
Colleague at Merck GroupArgentina
View →
ER
Eduard Rogalsky
Colleague at Merck GroupHainburg, Hesse, Germany
View →
LY
Lu Yeye
Colleague at Merck GroupChaoyang District, Beijing, China
View →
XL
Xincheng Liu
Colleague at Merck GroupShanghai, China
View →
AÇ
Anıl Çeli̇k
Colleague at Merck GroupAdapazarı Bucağı, Sakarya, Türkiye, Turkey
View →
4 education records
Dr. Harshad Kothawade education
Doctor Of Philosophy - Phd, Pharmaceutical Sciences, 1St
International Management Program (Imp), International Business
Merck University
Master'S Degree, Pharmaceutical Sciences, 1St
Mit College Of Pharmacy, Kothrud,Pune
Bachelor Of Pharmacy - Bpharm, Pharmacy, 1St
Svpms College Of Pharmacy
FAQ
Frequently asked questions about Dr. Harshad Kothawade
Quick answers generated from the profile data available on this page.
What company does Dr. Harshad Kothawade work for?
Dr. Harshad Kothawade works for Merck Group.
What is Dr. Harshad Kothawade's role at Merck Group?
Dr. Harshad Kothawade is listed as Director, Head of Regulatory Management and Trade Compliance India, South East Asia, ANZ at Merck Group.
What is Dr. Harshad Kothawade's email address?
AeroLeads has found 1 work email signal at @yahoo.co.in for Dr. Harshad Kothawade at Merck Group.
Where is Dr. Harshad Kothawade based?
Dr. Harshad Kothawade is based in Mumbai, Maharashtra, India while working with Merck Group.
What companies has Dr. Harshad Kothawade worked for?
Dr. Harshad Kothawade has worked for Merck Group, Famy Care Limited. Tie Up With Mylan Inc., Jb Chemicals & Pharmaceuticals Limited, Inventia Healthcare Limited, and Gsk Consumer Healthcare India.
Who are Dr. Harshad Kothawade's colleagues at Merck Group?
Dr. Harshad Kothawade's colleagues at Merck Group include Michelle Ricasa, Cpa, メルク 阿多隼人, Yi Qu, Myra Zmarsly, and Manuela Rojacher.
How can I contact Dr. Harshad Kothawade?
You can use AeroLeads to view verified contact signals for Dr. Harshad Kothawade at Merck Group, including work email, phone, and LinkedIn data when available.
What schools did Dr. Harshad Kothawade attend?
Dr. Harshad Kothawade holds Doctor Of Philosophy - Phd, Pharmaceutical Sciences, 1St from Sri Satya Sai University Of Technology & Medical Sciences, Sehore.
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