We at Veeda Clinical Research hiring for below mentioned position.
Position : Regulatory Affairs
Qualification : M.pharm
Experience : 3 – 6 Years
Location : Ahmedabad
Please find below job responsibilities, interested candidates may share their resume on hiral.v1791@veedacr.com
Job Responsibilities :
01. Regulatory visit DCGI’s website for molecule related regulatory feasibility assessment.
02. Reviewing of documents received from Project Managers and then preparing and filling of dossiers for biostudies for DCG(I) submission as per Schedule-Y of Drugs and cosmetics Act 1945.
03. Reviewing, Preparing and filling of dossiers seeking Import License for Investigational products for bio-studies /Clinical trials for DCG(I) submission as per Schedule Y of Drugs and Cosmetics Act 1945.
04. Reviewing, preparing and filling of dossiers seeking Export of biological samples of biostudies/Clinical Trials done in India for DCGI approval.
05. Reviewing, preparing and filling of dossiers seeking approval from ICMR, New Delhi for import of biological samples for analysis purpose.
06. Reviewing, preparing and filling of dossiers for getting Import Certificate from Central Bureau of Narcotics, Gwalior for Narcotic and Psychotic drugs.
07. Reviewing, preparing and submissions of SUSAR/SAE notifications as well as Annual progress reports of Global Phase II oncology Clinical Trials/regular bio-studies.
08. Coordinating with Consultant at Delhi pertaining to DCGI Office/ICMR related submissions and approvals.
09. Advise to Business Development team/Project Management Team and other concerned personnel pertaining regulatory related issues and also providing updates regarding changes done in the guidelines, notifications, amendment etc. time to time.