Rupak Mitra
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Rupak Mitra Email & Phone Number

Sr. Manager, Regulatory Affairs at AUROBINDO PHARMA LTD
Location: Hyderabad, Telangana, India 8 work roles 2 schools
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Current company
Role
Sr. Manager, Regulatory Affairs
Location
Hyderabad, Telangana, India

Who is Rupak Mitra? Overview

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Quick answer

Rupak Mitra is listed as Sr. Manager, Regulatory Affairs at AUROBINDO PHARMA LTD, based in Hyderabad, Telangana, India. AeroLeads shows a matched LinkedIn profile for Rupak Mitra.

Rupak Mitra previously worked as Fellow Regulatory at Graviti Pharma and Manager at Aurobindo Pharma. Rupak Mitra holds M.Pharm, Quality Assurance from Annamalai University.

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Email format at AUROBINDO PHARMA LTD

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AUROBINDO PHARMA LTD

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Profile bio

About Rupak Mitra

17 years of experience across all phases of drug product development and post- marketing.Expert in developing CMC regulatory strategies ensuring business goals, while maintaining regulatory compliance.A results oriented Regulatory affairs professional skilled in submission of high quality ANDAs to USFDA for Orals, Topical/TDS. My focus area is Chemistry Manufacturing Controls (CMC). I had also acquired experience in pharmaceutical manufacturing and quality assurance of solid orals.Specialities: ANDA submission, Query responses, Post approval submissions for Speciality products (Topical/TDS), Product life cycle management, Project evaluation and GAP analysis, Document management.I am a continuous learner, adaptive to changes and looking for logical ways to do the things to succeed.

Current workplace

Rupak Mitra's current company

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AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd
Sr. Manager, Regulatory Affairs
Hyderabad, IN
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8 roles · 19 years

Rupak Mitra work experience

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Sr. Manager, Regulatory Affairs

Hyderabad, Telangana, India

US regulatory submissions and other activities for Topical and TDS products.

Fellow Regulatory

Hyderabad, Telangana, India

US regulatory submissions and other related activities

Aug 2017 - Jul 2018

Manager

Aurobindo Pharma

Hyderabad Area, India

ANDA submissions, Deficiency response, pre development activities for Oral product.

Aug 2013 - Aug 2017

Regulatory Affairs Pofessional

Ahmedabad

Worked for US & Canada market.

Nov 2010 - Aug 2013

Executive Regulatory Affairs

Baroda, Gujarat

Worked for US & ROW markets.Exposure in US FDA audits.

2009 - 2010 ~1 yr

Executive Regulatory Affairs

Mumbai Area, India

Worked for ROW market & Query reponses.

2008 - 2009 ~1 yr

Officer - Regulatory Affairs

Mumbai

Worked for MHRA UK market.

May 2007 - Aug 2008
2 education records

Rupak Mitra education

M.Pharm, Quality Assurance

Activities and Societies: Quality Management, Analytical Method Development and Validation, Equipment qualification, Process validation I.

B.Pharmacy, Pharmaceutical Science, 1St

Himalayan Pharmacy Institute

i have done pharmacy graduation.

FAQ

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What company does Rupak Mitra work for?

Rupak Mitra works for AUROBINDO PHARMA LTD.

What is Rupak Mitra's role at AUROBINDO PHARMA LTD?

Rupak Mitra is listed as Sr. Manager, Regulatory Affairs at AUROBINDO PHARMA LTD.

Where is Rupak Mitra based?

Rupak Mitra is based in Hyderabad, Telangana, India while working with AUROBINDO PHARMA LTD.

What companies has Rupak Mitra worked for?

Rupak Mitra has worked for Aurobindo Pharma Ltd, Graviti Pharma, Aurobindo Pharma, Torrent Research Center, and Astral Steritech Pvt. Ltd..

How can I contact Rupak Mitra?

You can use AeroLeads to view verified contact signals for Rupak Mitra at AUROBINDO PHARMA LTD, including work email, phone, and LinkedIn data when available.

What schools did Rupak Mitra attend?

Rupak Mitra holds M.Pharm, Quality Assurance from Annamalai University.

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