Vikas Kumbhar Email and Phone Number
Vikas Kumbhar work email
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Vikas Kumbhar personal email
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Vikas Kumbhar is a General Manager - Regulatory Affairs at Glenmark Pharmaceuticals Ltd. at Glenmark Pharmaceuticals. Colleagues describe him as "Vikas is a knowledgeable, reliable and passionate regulatory professional. I know Vikas since 2011 when I joined Regulatory Affairs -US market team in Lupin Ltd., Mumbai. For many projects, including complex generics like Inhalations and Topical dosage forms, Vikas was my senior and final reviewer and I was fortunate to get his guidance in my first job as a Regulatory professional. It helped me develop my review skills by acquiring knowledge of regulatory requirements as well as… Show more" and "Vikas is very knowledgeable and cool person. His review skill is very strong. He have developed in himself patience. He is also skillful CMC writer. His communication is also strong.He have friendly nature. Under his review Lupin have filled complex dosage form ANDA's and got approved. He always use to refer guidances while working."
Glenmark Pharmaceuticals
View- Website:
- glenmarkpharma.com
- Employees:
- 11169
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General ManagerGlenmark Pharmaceuticals Jul 2022 - PresentMumbai, Maharashtra, India -
Deputy General Manager - Regulatory AffairsGlenmark Pharmaceuticals Ltd. Dec 2017 - Jun 2022Mumbai Area, India -
Manager Ii- Regulatory AffairsLupin May 2015 - Dec 2017Mumbai Area, India- Involvement in Regulatory Strategy and Original ANDA filing for Inhalation (MDI, DPI, Inhalation Solution) ANDA's, Ophthalmic, Injectable, Oral Solid Dosage Forms (NCE-1, F2F, Para-IV) - Involved in Regulatory Strategy and filing of Dermatology ANDA products Topical (Cream, Ointment, Gel, Lotion, Solution) and Transdermal (Solution, Gel) Dosage forms - Review of CC & CMC responses to FDA questions during development, product registration and product lifecycle. -
Manager I - Regulatory AffairsLupin Jun 2012 - Mar 2015Mumbai Area, India -
Sr. Executive - Regulatory AffairsLupin Sep 2009 - Apr 2012Mumbai Area, India -
Regulatory Associate-IiNovartis Jul 2008 - Oct 2009Hyderabad Area, IndiaPreparation, review and submission of CMC documentation during development and product registration i.e. IND/IMPD Phase-I, Phase-II, Phase-III and New drug application (NDA) submissions in CTD format for Europe and US. -
Executive - Regulatory AffairsFamy Care Ltd., Mumbai Feb 2008 - Jun 2008Mumbai Area, IndiaInvolved in First Dossier Filing of Oral Contraceptive Product of Famycare in Europe market -
Executive - Regulatory AffairsIpca Laboratories Limited Jul 2007 - Feb 2008Mumbai Area, India- Compilation, review and submission of Dossiers for Europe market for Oral Solid Dosage Forms - Preparation and filing of variations for approved MA’s in support of changes in manufacturing processes,analytical methods and specifications, product labeling and processing controls.- Review and submission of responses to deficiency letters received from various regulatory agencies. -
Officer - Regulatory AffairsIpca Laboratories Limited Aug 2004 - Jul 2005Mumbai Area, India -
Quality Assurance OfficerIndoco Remedies Ltd. May 2003 - Jul 2004Mumbai Area, India- Exposure to Quality Assurance System and Quality Audits- Experienced for chemical testing of various pharmaceutical products and packaging material.- Experienced for preparation of Annual product review and Standards Operating Procedures.- Exposed to the production of various pharmaceutical dosages forms, trouble shooting during production.
Vikas Kumbhar Education Details
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First Class -
Symbiosis Center For Distance Learning, Pune, IndiaFirst Class -
First Class
Frequently Asked Questions about Vikas Kumbhar
What company does Vikas Kumbhar work for?
Vikas Kumbhar works for Glenmark Pharmaceuticals
What is Vikas Kumbhar's role at the current company?
Vikas Kumbhar's current role is General Manager - Regulatory Affairs at Glenmark Pharmaceuticals Ltd..
What is Vikas Kumbhar's email address?
Vikas Kumbhar's email address is vi****@****ail.com
What schools did Vikas Kumbhar attend?
Vikas Kumbhar attended National Academy Of Legal Studies & Research (Nalsar) University Hyderabad, University Of Mumbai, Symbiosis Center For Distance Learning, Pune, India, University Of Mumbai.
Who are Vikas Kumbhar's colleagues?
Vikas Kumbhar's colleagues are Neel Shrestha, Vaman Raikar, Ketan Shah, Anil Kadam, Vinayak Jadhav, Mahesh Bhimavaram, Syed Thameem.
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