Work as Regulatory Coordinator @ Novartis Healthcare Pvt. Ltd.
The Regulatory Coordinator is responsible for providing operational regulatory and compliance support to the DRA global program team representative and/or GTAL on development projects/major line extensions through development, registration, and approval including post approval commitments.
-Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into compliance database (DRAGON). -Subject Matter Expert for regulatory compliance activities and supporting tools (eg DRAGON) providing support to DRA PIE in a matrix reporting environment to ensure HQ and CPO compliance with internal procedures governing health registration management, compliance reporting and HA commitment data management activities.
-Provides support for internal/external inspections. -Provide support as needed for Routine Health Authority submissions including Annual Reports, New Protocol Submissions, Protocol Amendment Submissions, etc. and act as main liaison with DRA Operations to ensure accurate and timely submissions to HAs. -Manage and execute drug shipping ticket review process (US).
-Support EudraVigilance/EVMPD activities – Facilitate the timely delivery of sections to compile the IND/IMPD (CTAs) and NDA/MAA/CTD for Health Authority submissions
– Assist in the preparation of regulatory deliverables (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables including responses to Health Authority queries)
– Support update of QPPV tracker – Provide operational support for obtaining up-to-date Regulatory Intelligence and other regulatory support Information Review Support the GPRD/GPRMs to ensure: Timely delivery of Safety Labeling change submissions Timely delivery of Routine Health Authority submissions Timely completion of Drug Shipping Process (US). Provide support for DRA responsible part of Pharmacogilence compliance Timely completion of Module #1 in the CTD Timely completion of briefing books for regulatory Health Authority meetings Timely delivery of IND/IMPD and NDA/MAA/CTD to Health Authorities Regulatory deliverables met (i.e. power-point presentations, excel spreadsheets, informal tracking for deliverables) Timely delivery of Regulatory Intelligence and other regulatory support information Completion of submissions to Health Authority.