Ravikiran Gouni

Angestellt, Senior Research Associate, Aurobindo Pharma Ltd
Abschluss: Master of Pharmacy (Pharmaceutics), Jawaharlal Nehru Technological University, Hyderabad
Hyderabad, India

Fähigkeiten und Kenntnisse

Regulatory Affairs
Generic drug
Pharmaceutical industry
Regulatory Filing
Regulatory documentation
Regulatory Compliance
Executive Search

Werdegang

Berufserfahrung von Ravikiran Gouni

  • Current 7 years and 3 months, since Mar 2019

    Senior Research Associate

    Aurobindo Pharma Ltd

  • 3 years, Mar 2016 - Feb 2019

    Senior Executive

    Strides Shasun Limited

    1. Involved in end-to-end product development activity. 2. Provide Regulatory filing strategy and formulation development support. 3. Liaising with US-FDA with Controlled Correspondence (CC), Comprehensive Generic Therapy (CGT) Grant and Presubmission Filing Correspondence (PFC). 4. Development, compilation (complete CMC and Labelling) and filing of high quality dossiers for USFDA.

  • 1 year and 5 months, Oct 2014 - Feb 2016

    Executive

    Amneal Pharmaceuticals

    Compilation of complete electronic submission, QC/ review of dossier & Validation per eCTD requirements. Working knowledge of tools used in support of publishing processes viz., ISI Toolbox, eCTD Xpress, Liquent insight Publisher and Validation Tools. Point of contact between Project Personnel and the Sponsor in order resolve queries (if any) related to project activities.

Ausbildung von Ravikiran Gouni

  • 2 years and 1 month, Dec 2012 - Dec 2014

    Pharmacy

    Jawaharlal Nehru Technological University, Hyderabad

    Pharmaceutical product development, Medicinal Chemistry, Organic Chemistry and Drug Regulatory Affairs.

  • 4 years and 1 month, Aug 2007 - Aug 2011

    Pharmacy

    Vinayaka Mission's Research Foundation, Deemed University

    Organic Chemistry, Inorganic chemistry, Pharmaceutical Technology, Posology, anatomy, Physiology and Health Education

Sprachen

  • English

    C1 (Fließend)

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