Vamshikrishna Veldandi

Hyderabad Area, India India

Looking for Regulatory affairs job opportunities ........

Medical / Health Care / Pharmaceuticals

I have done M.pharm in Pharmaceutics. My day to day activity was reated to analyzing post approval changes and filing the apppropriate document for approval of change in US market. I have worked on CTD filing for Annual Reportable Changes, CBE - 0, CBE- 30 and Prior Approval Supplement submission I have gained knowledge related to: Regulatory Affairs - Knowledge of post approval changes guidelines in US for CMC Changes. - Change control Management in Trackwise Software. - eCTD filing on DCM & Citrix Software. - Knowledge of Drug Approval Process in US. etc.