Sravani Kasina
Regulatory Professional i - Eu Ctr @Novo Nordisk
Signup · Get unlimited contacts
WORK HISTORY
Regulatory Professional i - Eu Ctr @Novo Nordisk
Bengaluru, IN
Handle Clinical Trial Application ( CTA ) submissions in EEA/ EU via CTISCoordinating activities related to planning, Compiling, Submission and approval of CTAs. Supporting throughout the full life cycle of the trial until the closure of CTA in EU/ EEA.Supporting with RFI submissions to ensure high quality and timely response.Preparing regulatory CTA documents and QC of CTAs before submission.Archiving and updating all submission related data in internal systems like Vault RIM and Vault Clinical.Taking the lead and drive projects to ensure alignment of and efficient and innovative processes supporting successful global submissions and reduced lead times and time to market.Skills : CTIS, Vault RIM, Vault Clinical and project Management and stakeholder management
EDUCATION
R.V.R & J.C. COLLEGE OF ENGINEERING
Bachelor of Technology (B.Tech.), Biotechnology
Andhra University College of Engineering
Master's Degree, Biotechnology
ABOUT SRAVANI KASINA
Regulatory, Clinical and Project Management Professional currently working as Regulatory Professional for CTA submissions in compliance with EU CTR. Previously worked as Project Coordinator in Regulatory Centralised Translation Projects helping internal stakeholders with optimised solutions in order to get the regulatory documents translations for LATAM and EU. Furthermore worked in Regulatory Publishing and Clinical Data Management as wellWell versed with Azure devops, Veeva Vault RIM and Clinical Vault ( COSMOS), CTIS and different submissions CP creation.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.