Bhavik Gondaliya

Angestellt, Head of Regulatory Affairs & PRRC, QualiMed Innovative Medizinprodukte GmbH
Winsen (Luhe), Germany

Fähigkeiten und Kenntnisse

Technical Documentation
FDA
ISO 13485
Regulatory Affairs
Medical device
Clinical Research
Medical Device Regulation
Biotechnology and Pharmaceuticals
MDSD
Compliance
Risk management
Pharmacy
Biology
Biotechnology
English Language
Lifecycle Management
Pharmaceutical industry
Team leadership
Clinical Trials
Drug Manufacturing
Drug Development
Medical device regulation (MDR)
Product Registration
CAPA
QMS
Validation
GMP
ISO
Quality Management
Research and Development
Audit
Regulatory Compliance
Regulatory documentation
Regulatory Strategy
Regulatory Submission
Team Collaboration
Project Management
Regulatory Representation
CMC Documentation
Scientific Writing
Scientific Knoweldge and Expertise
Life Cycle Management
Change Control
Regulatory Impact Assessment
Health Authority Query Resolution
Stratgic Planning
Adaptbility
Continuous Learning
SOP
QSR
Natural Science
Biologicals/Biosimilars product development
Drug-Device Combination Product Development
Lyophilized and Liquid sterilized products
Sterile Injectables
IVD
Pharmaceutical Technology
attention to detail
Organizational skills
Communication skills
Analytical skills
Critical thinking
problem solving skills
Flexibility

Werdegang

Berufserfahrung von Bhavik Gondaliya

  • Current 7 years and 3 months, since Mar 2019

    Head of Regulatory Affairs & PRRC

    QualiMed Innovative Medizinprodukte GmbH

  • 1 year and 11 months, Apr 2017 - Feb 2019

    Regulatory Affairs Manager

    Meril Life Sceinces Private Limited

  • 1 year, Apr 2016 - Mar 2017

    Assistant Manager - Regulatory Affairs

    Meril Life Sciences Private Limited

  • 5 years and 3 months, Jan 2011 - Mar 2016

    Sr. Executive - Regulatory Affairs

    Meril Life Sciences Private Limited

  • 9 months, Apr 2010 - Dec 2010

    Quality Assurance Officer

    USV Ltd

  • 8 months, Aug 2009 - Mar 2010

    Quality Assurance - Jr. Executive

    Lyka Labs Ltd.

Ausbildung von Bhavik Gondaliya

  • 2007 - 2009

    M. Pharm (Pharmaceutics)

    Rajiv Gandhi Proudyogiki Vishwavidyalaya

  • 2003 - 2007

    Bachelor of Pharmacy (B.Pharm)

    Saurashtra University

Sprachen

  • English

    C1 (Fließend)

  • German

    A1-A2 (Grundkenntnisse)

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