Tapan Narulkar

Regulatory Affairs in Drugs (injectable, complex injectable, oral and semi solid dosage forms) & Combination products

Role
Associate Manager Ii - Regulatory Cmc Devices at 화이자
Location
Chennai, TN, IN
LinkedIn followers
500 followers

About Tapan Narulkar

10+ years of working experience in Pharmaceutical industry with 8 years of Regulatory…

Experience

  1. Associate Manager Ii - Regulatory Cmc Devices

    화이자

    Nov 2022 — Present · Chennai, IN

    Maintenance of Life cycle of MDCP products (Medical Devices and Combination products) such as Pre-filled syringes, Pre-filled pen, Nasal spray, co-packaged kits globally in markets like US, EU, APAC, GCC etc- Review and approval of regulatory aspects of Design History files (DHF) documents for MDCPs- Working on various regulatory submissions like new as well variations in global markets

Skills

  • Quality Assurance
  • Teaching
  • Anda
  • Public Speaking
  • Biotechnology
  • Packaging
  • Validation
  • Regulatory Documentation
  • Windows
  • Microsoft Office
  • Outlook
  • Research
  • Regulatory Affairs
  • Microsoft Excel
  • Powerpoint
  • Regulatory Submissions
  • Strategic Planning
  • Pharmaceutical Industry
  • Sop
  • Fda
  • Product Development
  • Gmp
  • Medical Devices
  • Clinical Research
  • Pharmaceutics
  • Regulatory Requirements
  • Microsoft Word
  • English
  • Clinical Trials

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Tapan Narulkar — Associate Manager Ii - Regulatory Cmc Devices at 화이자 in Chennai, TN, IN | Unifers