Shanti Rodriguez
Clinical Operations | Regulatory Submissions | Phase I-III | Oncology | Hematology | Autoimmune
- Role
- Global Regulatory Submissions at Immunovant
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Shanti Rodriguez
As a multifaceted biotech and pharmaceutical professional with 20+ years of experience, I…
Experience
Global Regulatory Submissions
Oct 2024 — Present · NY, US
Point of contact for delivery of global EU CTR and MHRA Clinical Trial Application submission documents• Coordinate with study team, CRO, and submissions vendor for document collection and submission• Central point to triage all EU and UK submissions work from planning, submission building, to handling of incoming requests for information• Assess requests for information related to the validation and assessment process and coordinate with the study team, CRO, and submissions vendor for timely responses to Health Authorities • Determine document translation and redaction requirements and manage the translation process to include preparation and submission of documents to translation vendors, as well as QC of Certificates of Translation • Perform QC of submission documents prior to submission to CTIS• Responsible for ensuring archival of submissions in Microsoft SharePoint and Veeva RIM, to include cataloging and indexing • Life Cycle management
Education
Southern New Hampshire University
Bachelor of Science - BS
2023 — 2027
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.