Dr. Smita BhuyanSenior Device Development Manager

Smita is a scientist by training and regulatory affairs manager by profession. She is specialized in late phase clinical trials and post market observational/surveillance studies with drugs and medical devices.

She was leading the Regulatory Affairs department in a CRO in her previous role. Smita has a strong background and in-depth knowledge of National / European / International regulations for clinical trials.

She has expertise in interpreting applicable regulations for precise preparation and submissions/communication with regulatory authorities, maintenance of regulatory knowledge database along with coaching/mentoring of team members.


  • Drug Development
  • Regulatory Affairs
  • Medical Writing
  • QM/QC, GCP
  • Clinical trials
  • Cardiovascular
  • Oncology
  • Respiratory

contact Smita

LinkedIn Profile