Suresh Kumar Ch
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Suresh Kumar Ch Email & Phone Number

Deputy General Manager-Regulatory Affairs at Amneal Pharmaceuticals at Amneal Pharmaceuticals
Location: Ahmedabad, Gujarat, India 8 work roles 3 schools
4 work emails found @amneal.com 1 phone found area 732 LinkedIn matched
✓ Verified Jul 2026 4 data sources Profile completeness 100%

Contact Signals · 4 work emails · 1 phone

Work email s****@amneal.com
Direct phone (732) ***-****
LinkedIn Profile matched
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Current company
Role
Deputy General Manager-Regulatory Affairs at Amneal Pharmaceuticals
Location
Ahmedabad, Gujarat, India
Company size

Who is Suresh Kumar Ch? Overview

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Quick answer

Suresh Kumar Ch is listed as Deputy General Manager-Regulatory Affairs at Amneal Pharmaceuticals at Amneal Pharmaceuticals, a with 3128 employees, based in Ahmedabad, Gujarat, India. AeroLeads shows a work email signal at amneal.com, phone signal with area code 732, and a matched LinkedIn profile for Suresh Kumar Ch.

Suresh Kumar Ch previously worked as Deputy General Manager-Regulatory Affairs at Amneal Pharmaceuticals and Asst.General Manager-Regulatory Affairs (API's) at Amneal Pharmaceuticals. Suresh Kumar Ch holds B.Sc., Chemistry, Botany & Zoology from Andhra University.

Company email context

Email format at Amneal Pharmaceuticals

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{first_initial}{last}@amneal.com
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Profile bio

About Suresh Kumar Ch

Over 18+ years of enriched experience in Regulatory Affairs & QA both Sterile and Non-sterile domain. Well-versed with filings of quality DMFs' in US, EU, Canada, WHO, Australia and CEPs' with EDQM & HealthCare. Sound knowledge of Analytical, Quality Assurance, Aseptic Process and Technology Transfer activities. Expertise in drafting clear responses to deficiencies raised by Regulators and Global customers , Familiar with Life cycle management of DMFs' & CEPs'., Good understanding and knowledge of R&D related activities especially wrt Process development & control strategies and Cross-functional training.Well-versed with Sterility Assurance (Aseptic Process) of Injectable API and formulation facilities.Possess project management skills, People management skills, Good understanding of regulatory requirements, cGMP & Compliance for US & EU and other Regulated markets. Established team building and leadership skills. Good in problem solving skills.Had a shop-floor experience in Quality Control, Microbiology and Quality Assurance. Have lead teams that have submitted +120 US DMFs' and + 65 EU DMFs' (NA/DCP/MRP) and + over 50 Canadian DMFs', 25 CEPs' and etc. in overall experience.

Listed skills include Validation, Fda, Regulatory Requirements, V&V, and 4 others.

Current workplace

Suresh Kumar Ch's current company

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Amneal Pharmaceuticals
Amneal Pharmaceuticals
Deputy General Manager-Regulatory Affairs at Amneal Pharmaceuticals
bridgewater, new jersey, united states
Website
Employees
3128
AeroLeads page
8 roles

Suresh Kumar Ch work experience

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Deputy General Manager-Regulatory Affairs

Current

Ahmedabad

Responsible and accountable for DMF filings

Jan 2020 - Present

Asst.General Manager-Regulatory Affairs (Api'S)

Vishakhapatnam Area, India

Jan 2017 - Dec 2019

Manager-Regulatory Affairs

Vishakhapatnam Area, India

Taking care of Regulatory functions at 2 API manufacturing sites and R&D facility

Jun 2013 - Mar 2014

Deputy Manager-Regulatory Affairs

Bangalore

Responsible for DMF/ CEP's filing for US, Canada, Europe, RoW and etc. Regulatory support to R&D for new molecules (under pipeline) and already established moleculesWriting clear responses (Debate/Explanation) to Regulatory authorities and key customersVendor evaluation for KSM in regulatory prospective.Proficient in Genotoxic assessmentRegulatory Audit compliance and etc..

Nov 2010 - May 2013

Asst. Manager-Regulatory Affairs & Cqa

Aurobindo Pharma

Hyderabad Area, India

• Involvement in CMC documentation for preparing, amending and updating the Drug Master Files (DMFs) / CEP’s/ Common Technical Documents (CTDs) of APIs as per USFDA (Type-II & Type-V DMF’s), EDQM & Health Care, Health Canada (Type-I CDMF’s) TGA, WHO (APIMF’s) and other regulatory authorities requirements.• Preparation of responses on Regulatory authority’s queries / deficiencies as per current regulatory requirements.• Expertise on “Sterilization and Aseptic Process” of Sterile API’s/ Injectable formulations.. Regulatory support for ANDA/ MAA team w.r.t Sterility Assurance and Aseptic process activities

Feb 2007 - Oct 2010

Management Staff-Quality Assurance

Pune Area, India

Worked as a Validation team head in Quality Assurance. Familiar with all key validation i.e. Water system, Analytical Method validations, Cleaning and HVAC System validations. Expertise on evaluation of Change Controls, Deviations and OOS. Established Quality Management system. Actively participated in Regulatory Audits i.e.US-FDA, WHO and other customer's domestic & overseas audits.

Feb 2006 - Feb 2007

Sr.Chemist / Qc

Hyderabad Area, India

•Responsible for Quality Control related activities•Preparation of SOP’s, Specifications, CoA’s, Method of Analysis and Validation protocols•Microbiological Analysis of Water, Raw materials and Finished API •Evaluation of Clean rooms by Environmental Monitoring study•Familiar with Chromatography•Calibration of Quality Control related equipments

Jun 2003 - Feb 2006
Team & coworkers

Colleagues at Amneal Pharmaceuticals

Other employees you can reach at amneal.com. View company contacts for 3128 employees →

3 education records

Suresh Kumar Ch education

FAQ

Frequently asked questions about Suresh Kumar Ch

Quick answers generated from the profile data available on this page.

What company does Suresh Kumar Ch work for?

Suresh Kumar Ch works for Amneal Pharmaceuticals.

What is Suresh Kumar Ch's role at Amneal Pharmaceuticals?

Suresh Kumar Ch is listed as Deputy General Manager-Regulatory Affairs at Amneal Pharmaceuticals at Amneal Pharmaceuticals.

What is Suresh Kumar Ch's email address?

AeroLeads has found 4 work email signals at @amneal.com for Suresh Kumar Ch at Amneal Pharmaceuticals.

What is Suresh Kumar Ch's phone number?

AeroLeads has found 1 phone signal(s) with area code 732 for Suresh Kumar Ch at Amneal Pharmaceuticals.

Where is Suresh Kumar Ch based?

Suresh Kumar Ch is based in Ahmedabad, Gujarat, India while working with Amneal Pharmaceuticals.

What companies has Suresh Kumar Ch worked for?

Suresh Kumar Ch has worked for Amneal Pharmaceuticals, Biocon, Aurobindo Pharma, Cipla, and Neuland Laboratories Limited.

Who are Suresh Kumar Ch's colleagues at Amneal Pharmaceuticals?

Suresh Kumar Ch's colleagues at Amneal Pharmaceuticals include Yogesh Mahale, Parth Pokar, Rathwa Pritam, Jaymin Patel, and Lagniben Patel.

How can I contact Suresh Kumar Ch?

You can use AeroLeads to view verified contact signals for Suresh Kumar Ch at Amneal Pharmaceuticals, including work email, phone, and LinkedIn data when available.

What schools did Suresh Kumar Ch attend?

Suresh Kumar Ch holds B.Sc., Chemistry, Botany & Zoology from Andhra University.

What skills is Suresh Kumar Ch known for?

Suresh Kumar Ch is listed with skills including Validation, Fda, Regulatory Requirements, V&V, Change Control, Aseptic Processing, Regulatory Submissions, and Cleaning Validation.

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