Deputy General Manager-Regulatory Affairs
CurrentResponsible and accountable for DMF filings
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@amneal.com
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1 phone found area 732
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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.
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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.
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Ahmedabad
Responsible and accountable for DMF filings
Vishakhapatnam Area, India
Taking care of Regulatory functions at 2 API manufacturing sites and R&D facility
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..
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
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.
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
Other employees you can reach at amneal.com. View company contacts for 3128 employees →
Yogesh Mahale
Colleague at Amneal PharmaceuticalsNashik, Maharashtra, India
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Parth Pokar
Colleague at Amneal PharmaceuticalsAhmedabad, Gujarat, India
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Rathwa Pritam
Colleague at Amneal PharmaceuticalsIndore, Madhya Pradesh, India
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JP
Jaymin Patel
Colleague at Amneal PharmaceuticalsAhmedabad, Gujarat, India
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Lagniben Patel
Colleague at Amneal PharmaceuticalsWoodbridge, New Jersey, United States
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Digvijay Yadav
Colleague at Amneal PharmaceuticalsJersey City, New Jersey, United States
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PP
Prathyusha Peechara
Colleague at Amneal PharmaceuticalsPiscataway, New Jersey, United States
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VK
Viplove Kataria
Colleague at Amneal PharmaceuticalsAhmedabad, Gujarat, India
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DM
David Miller
Colleague at Amneal PharmaceuticalsChatham, New Jersey, United States
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SC
Sara Copp
Colleague at Amneal PharmaceuticalsNew York City Metropolitan Area, United States
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Quick answers generated from the profile data available on this page.
Suresh Kumar Ch works for Amneal Pharmaceuticals.
Suresh Kumar Ch is listed as Deputy General Manager-Regulatory Affairs at Amneal Pharmaceuticals at Amneal Pharmaceuticals.
AeroLeads has found 4 work email signals at @amneal.com for Suresh Kumar Ch at Amneal Pharmaceuticals.
AeroLeads has found 1 phone signal(s) with area code 732 for Suresh Kumar Ch at Amneal Pharmaceuticals.
Suresh Kumar Ch is based in Ahmedabad, Gujarat, India while working with Amneal Pharmaceuticals.
Suresh Kumar Ch has worked for Amneal Pharmaceuticals, Biocon, Aurobindo Pharma, Cipla, and Neuland Laboratories Limited.
Suresh Kumar Ch's colleagues at Amneal Pharmaceuticals include Yogesh Mahale, Parth Pokar, Rathwa Pritam, Jaymin Patel, and Lagniben Patel.
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.
Suresh Kumar Ch holds B.Sc., Chemistry, Botany & Zoology from Andhra University.
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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