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Yogesh Virkhade

Global Regulatory Affairs Professional at Novo Nordisk I Ex-Novartis l NCE l Biologics l CMC l ANDAs

Role
Senior Regulatory Professional at Novo Nordisk
Location
Bengaluru, KA, IN
LinkedIn followers
500 followers
ScienceView LinkedIn profile

About Yogesh Virkhade

Seasoned Regulatory Affairs professional with a proven track record of over 15 years, specialised in regulatory submissions for original and Life Cycle Management (LCM) across global markets including the U.S, EU, Canada, Japan etc. Proficient in navigating regulatory requirements for Biological and Small Molecule products and offer comprehensive expertise in global regulatory strategies and execution. People Management experience – where leading regulatory team, fostering collaboration and high-quality execution.I excel in collaborative team environments, leveraging strong leadership, interpersonal, and assertive communication skills. I hold a Master degree M.S. pharm.(Biotechnology) from the National Institute of Pharmaceutical Education & Research (NIPER), Mohali, Punjab, India.I bring a unique blend of analytical prowess, innovative thinking, and a dedication to continuous advancement and growth.

Experience

  1. Senior Regulatory Professional

    Novo Nordisk

    Nov 2024 — Present · Bengaluru, IN

    Working as Regulatory Strategic Product Lead, responsible for Global Regulatory Submission for marketed portfolio• Leading LCM CMC submission management group, overseeing regulatory activities across the product lifecycle • Handling the query responses raised by health authority, stakeholders and local regulatory colleagues• Assessment of change control documents and build appropriate regulatory filing strategy• Close collaboration with local regulatory colleague and external partners/ companies for seamless regulatory strategies• Proficient in using Veeva Vault for regulatory documentation and submission management• Strong stakeholder management capabilities across cross-functional and global teams• Drive team success through hands-on leadership, mentorship, and a culture of collaboration.

Education

  • Institute of Diploma in Pharmacy

    D. Pharmacy, Pharmaceutical Sciences

    2004 — 2006

  • Institute of Pharmaceutical Education & Research

    Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences

    2006 — 2009

  • NATIONAL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH

    M.S. Pharm, Biotechnology

    2009 — 2011

Skills

  • Drug Delivery
  • Gmp
  • Anda
  • Regulatory Submissions
  • Pharmaceutical Research
  • Ectd
  • V&V
  • Regulatory Requirements
  • Therapeutic Areas
  • Pharmacology

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