Adhithya Aravindan
Associate| GRAAS Operations | Clinical Trial Submissions Management| Amgen-Hyderabad | M Pharm | Department of Pharmaceutics | 2022-2024 | Manipal College of Pharmaceutical Sciences |
- Role
- Associate Graas Operations at Amgen
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Adhithya Aravindan
Regulatory Affairs professional with ~3 years of experience in global submissions…
Experience
Associate Graas Operations
Jun 2025 — Present · Hyderabad, IN
Actively support EU Regulatory Leads (EURL), Local Trial Managers (LTM), and Global Trial Managers (GTM) in driving end-to-end Clinical Trial Application (CTA) submissions under the EU Clinical Trials Regulation (EU CTR) using the EMA Clinical Trial Information System (CTIS). Ensure regulatory compliance and successful execution across all submission types—Initial Application, Substantial/Non-Substantial Modifications, Addition of Member States (AMSC), IMPD-Q-only applications, and new Modules.Coordinate and track full RFI lifecycle for Part I and Part II—including triage, document formatting, response preparation, metadata accuracy, and timely submissions. Responsible for redaction and classification of “For Publication” vs. “Not for Publication” documents; apply metadata removal and content synchronization techniques to ensure CTIS readiness.Monitor CTIS Notices and Alerts daily—tracking Decision Submitted (MSC/Final), Validation Outcomes, RFI notices, Part I/II Conclusions, and Submission Statuses—to prevent delays or lapses. Maintain strict version control, track document integrity, and support audit-readiness across systems.Submissions and RFIs are archived systematically using Veeva Vault and Vault File Manager. Collaborate with Clinical Operations, Medical Writing, Regulatory Publishing, and cross-functional stakeholders to streamline timelines, troubleshoot issues, and maintain compliance.Also provide regulatory support for Canada CTA submissions by executing 50% retrospective quality review in CANDA. Adept in using Veeva Vault, Adobe Acrobat Pro, Adobe Design for formatting, metadata removal, and publishing deliverables.Tools: EMA CTIS, Veeva Vault, Vault File Manager, CANDA, Adobe Suite. Proficient in aligning submissions with evolving regulatory guidelines and supporting global team collaboration.
Education
Gujarat Technological University (GTU)
Bachelor of Pharmacy - BPharm
2018 — 2022
Manipal Academy of Higher Education
Masters of Pharmacy
2022 — 2024
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