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