Sandoz Canada Inc.
- Intern clinical/regulatory affairs
2009 - 2010Clinical Research
•Gained good knowledge on Clinical Research (phase I to IV, Bioequivalence studies) and GCP
•Wrote and revised of Clinical Standard Operations Procedures (SOPs).
•Review of clinical trials protocols (Bioequivalence and Pharmacodynamic Studies).
•Gained good knowledge on Clinical Research (phase I to IV, Bioequivalence/Pharmacodynamic studies) and GCP
•Authored a thesis on clinical challenges related to the development of generic dermatological drug in the scope of my graduate studies
Regulatory Affairs:
•Wrote of Post Approval dossier to the FDA for the drugs which will be manufactured in the new Sandoz facility.
•Contributed to the preparation of regulatory dossiers (CTD).
•Participated in cross-functional team meetings.
•Participated to the revision of regulatory SOPs.
•Writing of patent validity analyses.
•Good knowledge of the Chemistry Manufacturing and Control process.
•Regulatory Monitoring.
