Vikas Kumbhar

Vikas Kumbhar Email and Phone Number

General Manager - Regulatory Affairs at Glenmark Pharmaceuticals Ltd. @ Glenmark Pharmaceuticals
bombay, maharashtra, india
Vikas Kumbhar's Location
Mumbai, Maharashtra, India, India
Vikas Kumbhar's Contact Details

Vikas Kumbhar work email

Vikas Kumbhar personal email

About Vikas Kumbhar

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."

Vikas Kumbhar's Current Company Details
Glenmark Pharmaceuticals

Glenmark Pharmaceuticals

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General Manager - Regulatory Affairs at Glenmark Pharmaceuticals Ltd.
bombay, maharashtra, india
Employees:
11169
Vikas Kumbhar Work Experience Details
  • Glenmark Pharmaceuticals
    General Manager
    Glenmark Pharmaceuticals Jul 2022 - Present
    Mumbai, Maharashtra, India
  • Glenmark Pharmaceuticals Ltd.
    Deputy General Manager - Regulatory Affairs
    Glenmark Pharmaceuticals Ltd. Dec 2017 - Jun 2022
    Mumbai Area, India
  • Lupin
    Manager Ii- Regulatory Affairs
    Lupin May 2015 - Dec 2017
    Mumbai 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.
  • Lupin
    Manager I - Regulatory Affairs
    Lupin Jun 2012 - Mar 2015
    Mumbai Area, India
  • Lupin
    Sr. Executive - Regulatory Affairs
    Lupin Sep 2009 - Apr 2012
    Mumbai Area, India
  • Novartis
    Regulatory Associate-Ii
    Novartis Jul 2008 - Oct 2009
    Hyderabad Area, India
    Preparation, 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.
  • Famy Care Ltd., Mumbai
    Executive - Regulatory Affairs
    Famy Care Ltd., Mumbai Feb 2008 - Jun 2008
    Mumbai Area, India
    Involved in First Dossier Filing of Oral Contraceptive Product of Famycare in Europe market
  • Ipca Laboratories Limited
    Executive - Regulatory Affairs
    Ipca Laboratories Limited Jul 2007 - Feb 2008
    Mumbai 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.
  • Ipca Laboratories Limited
    Officer - Regulatory Affairs
    Ipca Laboratories Limited Aug 2004 - Jul 2005
    Mumbai Area, India
  • Indoco Remedies Ltd.
    Quality Assurance Officer
    Indoco Remedies Ltd. May 2003 - Jul 2004
    Mumbai 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

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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