Prathibha H Gowda

Prathibha H Gowda Email and Phone Number

Drug Regulatory Affairs- Lead Consultant @ Genpact
Bengaluru, KA, IN
Prathibha H Gowda's Location
Bengaluru, Karnataka, India, India
About Prathibha H Gowda

Around 13.6 years of pharmacetical industry experience in Drug Regulatory affairs and Compliance- Extensive experience in Review and authoring of formulation, analytical development data and related CMC data required for Regulatory submissions.- US regulatory filings for injectables - Authored, compiled, published ANDAs, and related submissions; amendments, supplements to USFDA (Module 1, 2 and 3).- Have had thorough experience in quality compliance, internal auditing (for Solid orals & injectable generic development in R & D), implementing quality systems in R & D based on Quality by Design.- Experienced in Regulatory information management system (RIMS) data cleansing and data enrichment for migration to Veeva vault or MEDIVA system.Additionally having about 2 years experience working in social development sector.

Prathibha H Gowda's Current Company Details
Genpact

Genpact

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Drug Regulatory Affairs- Lead Consultant
Bengaluru, KA, IN
Website:
genpact.com
Employees:
132692
Prathibha H Gowda Work Experience Details
  • Genpact
    Drug Regulatory Affairs- Lead Consultant
    Genpact
    Bengaluru, Ka, In
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  • Genpact
    Lead Consultant
    Genpact Feb 2021 - Present
    Mumbai, Maharashtra, India
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  • Sabbatical Break
    Volunteering For Social Work/Employed In Social Development Sector
    Sabbatical Break Jul 2016 - Jan 2021
    View
  • Apotex Research Private Limited
    Team Leader - Regulatory Affairs
    Apotex Research Private Limited Oct 2015 - Jun 2016
    Bengaluru, Karnataka, India
    View
  • Sciformix
    Senior Regulatory Affairs Specialist
    Sciformix Nov 2014 - Oct 2015
    Pune, Maharashtra, India
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  • Mylan
    Senior Executive- Regulatory Affairs
    Mylan Feb 2010 - Oct 2014
    Bangalore Urban, Karnataka, India
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  • Dr. Reddy'S Laboratories
    Junior Manager - Dqa- Product Development Quality Compliance
    Dr. Reddy'S Laboratories Jul 2007 - Aug 2008
    Hyderabad, Telangana, India
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  • Torrent Research Centre
    Scientist Ii- R & D Qa
    Torrent Research Centre May 2005 - Jun 2007
    Ahmedabad, Gujarat, India

Prathibha H Gowda Education Details

Frequently Asked Questions about Prathibha H Gowda

What company does Prathibha H Gowda work for?

Prathibha H Gowda works for Genpact

What is Prathibha H Gowda's role at the current company?

Prathibha H Gowda's current role is Drug Regulatory Affairs- Lead Consultant.

What schools did Prathibha H Gowda attend?

Prathibha H Gowda attended Rajiv Gandhi University Of Health Sciences.

Who are Prathibha H Gowda's colleagues?

Prathibha H Gowda's colleagues are Kiran Jha, Shubham Verma, Jayasudha Racherla, Nimish Sudama, Narendra Sharma, Junaid Nawaz Bhat, Bijimalla Ratnakar.

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