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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
Location: Mumbai, Maharashtra, India 9 work roles 4 schools
1 work email found @yahoo.co.in LinkedIn matched
✓ Verified May 2026 4 data sources Profile completeness 86%

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Current company
Merck Group
Role
Director, Head of Regulatory Management and Trade Compliance India, South East Asia, ANZ
Location
Mumbai, Maharashtra, India
Company size
31759 employees

Who is Dr. Harshad Kothawade? Overview

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Dr. Harshad Kothawade is listed as Director, Head of Regulatory Management and Trade Compliance India, South East Asia, ANZ at Merck Group, a company 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
Merck Group
Director, Head of Regulatory Management and Trade Compliance India, South East Asia, ANZ
Mumbai, MH, IN
Website
merckgroup.com
Employees
31759
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9 roles

Dr. Harshad Kothawade work experience

A career timeline built from the work history available for this profile.

Director, Head Of Regulatory Management And Trade Compliance India, South East Asia, Anz

Merck Group

Mumbai, MH, IN

Director, Head Of Regulatory Management & Trade Compliance India, South East Asia, Anz

Current
Merck Group

India

  • 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.
  • 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.
  • Spearheading the IND/NDA Submissions, ANDA Submissions, EU Submissions, DMF Submission, pre submission facility correspondence with Authorities, product lifecycle management
Apr 2022 - Present

Head Of Regulatory Management & Trade Compliance, India

Merck Group

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.
  • 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.
  • Spearheading the IND/NDA Submissions, ANDA Submissions, EU Submissions, DMF Submission, pre submission facility correspondence with Authorities, product lifecycle management
Aug 2017 - Mar 2022

Head Of Regulatory Affairs

Merck Group

India

Apr 2015 - Jul 2017

Manager Regulatory Affairs

Merck Group

India

Dec 2013 - Mar 2015

Manager Drug Regulatory Affairs

Famy Care Limited. Tie Up With Mylan Inc.

India

  • 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.
  • 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

India

  • 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.
  • 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

Inventia Healthcare Limited

India

  • 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.
  • 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

Gsk Consumer Healthcare India

India

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 →

JJ Jyolsna Joseph Jyolsna Joseph Colleague at Merck Group Dundalk, County Louth, Ireland, Ireland View → FP Fabrice Pereira Fabrice Pereira Colleague at Merck Group Noyon, Hauts-de-France, France, France View → JP Johana Paola Briceño Avila Johana Paola Briceño Avila Colleague at Merck Group Colombia, Colombia View → DK Dan Kotzer Dan Kotzer Colleague at Merck Group Israel, Israel View → MR Marilena Rosso Marilena Rosso Colleague at Merck Group Turin, Piedmont, Italy, Italy View → DB Dr Bhishak Pankhania Phd Dr Bhishak Pankhania Phd Colleague at Merck Group United Kingdom, United Kingdom View → NK Nitesh Kalal Nitesh Kalal Colleague at Merck Group Bengaluru, Karnataka, India, India View → AA As Adatul Umamah As Adatul Umamah Colleague at Merck Group United States, United States View → IW Ivy Wan Ivy Wan Colleague at Merck Group China, China View → SK Seongmi Kim Seongmi Kim Colleague at Merck Group South Korea, Korea, Republic Of View →
4 education records

Dr. Harshad Kothawade education

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 Jyolsna Joseph, Fabrice Pereira, Johana Paola Briceño Avila, Dan Kotzer, and Marilena Rosso.

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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