Nikita Narayanan

About Nikita Narayanan

With over 1.5 years of experience as an Advanced Quality Advisor at Novo Nordisk, I focus on ensuring compliance with regulatory standards by reviewing and approving deviations, SOPs, and change requests. Additionally, I provide quality support during audits and inspections to enhance operational integrity and maintain high standards of patient safety. My professional background also includes roles such as Freelance Content Editor and Chief Medical Writer, where I developed expertise in scientific writing, editing, and content management. By leveraging skills in patient safety, safety surveillance, and publications, I am committed to driving excellence in quality assurance and effective communication in the pharmaceutical industry.

Experience

1. Senior Regulatory Consultant

   Pharmaceutical Econsulting

   Mar 2026 — Present

   Manage projects and submissions, ensuring compliance with global regulatory requirements. • Compile eCTD, NeeS, and other submissions for various health authorities worldwide. • Conduct quality control and quality assurance of submissions to maintain high standards. • Provide regulatory research and regulatory intelligence.• Support data migration and consulting assignments.

Education

• Kannur University Campus

  Master's degree, Biotechnology

  2003 — 2006

• Ursuline Senior Secondary School

  X

  1988 — 1998

• Sree Narayana College

  Bachelor's degree, Zoology/Animal Biology

  2000 — 2003

• Bharathiya Vidya Bhavan

  XII, Physics, Chemistry, Biology

  1998 — 2000

Skills

• Copy Editing
• Clinical Trials
• Medical Writing
• Biochemistry
• Regulatory Submissions
• Editing
• Content Management
• Biotechnology
• Sop
• Ich-Gcp
• Molecular Biology
• Proofreading
• Microbiology
• Content Development
• Web Content Management
• Publishing
• Scientific Writing
• Research