Sunita Vora
Senior Regulatory Affairs Associate at Parexel
- Role
- Senior Regulatory Affairs Associate at Parexel
- Location
- South Delhi, IN
- LinkedIn followers
- 500 followers
About Sunita Vora
Experienced in Drug Regulatory Affairs with a demonstrated history of working in the pharmaceuticals industry with about 9 years of total experience. Skilled in Clinical Research, CRO Management, Regulatory Affairs, Clinical Trial Applications - Country Regulatory Submissions for iCTA, Amendments, EOT and other notifications, and Good Clinical Practice (GCP). Strong legal professional with a Master of Science (MSc) focused in Clinical Research from Amity University. I possess excellent communication skills, allowing for the cultivation of positive and business relationships, while keeping strong ethics at the forefront of my goals.
Experience
Senior Regulatory Affairs Associate
Mar 2022 — Present · New Delhi, IN
CTA, Regulatory Affairs Lead - Clinical Trial Regulatory Services* •Management of regulatory submissions for Multi Country trial by coordination with local regulatory contact and primary point of contact with sponsor for regular update on the progress of trial. •Responsible for the coordination, preparation, compilation, review of documents/dossiers for regulatory submission for Clinical Trial Applications. •Expertise in preparation of core master packages as well as country specific…
Education
Amity University
Master of Science (MSc), Clinical Research, CGPA 9.22
2013 — 2015
Institute of Good Manufacturing Practices India (IGMPI)
PG Diploma, Pharmaceutical Chemistry
2021 — 2022
Meera Bai Institute of Technology (MBIT)
Diploma, Clinical Laboratory Science/Medical Technology/Technologist, 75%
2008 — 2011
YWCA of Delhi
Bachelor's degree, Clinical Laboratory Science/Medical Technology/Technologist, 78%
2011 — 2013
Bioinformatics Institute of India
PG Diploma, Industry Program Diploma in Pharmaceutical Regulatory Affairs, 77%
2018 — 2019
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