Job Description Summary
-Provides effective operational and regulatory support to Novartis as well as to regional/global organizations for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities.
Job Description
Major accountabilities:
- Coordinates and prepares high quality submissions of regulatory dossiers for assigned products -Achieve the CTA/NDA submission on the targeted date; -Achieve the approval of CTA, NDA and other related supplementary application on the targeted date; -Ensure license renewal Submission and approval on time; -Ensure CMC/BPI/PSUR/RMP in line with NMPA regulation and Novartis internal policies; -Ensure registration master file update -Assist to coordinate f2f meeting with CFDA/CDE for new project discussion -Communicate the questions referred by HAs timely and smoothly; -Timely update and communicate the registration status to the line manager -Timely order and tracking the registration sample, dossier, certificates…; -Start to establish good communication and relationship with key stake holders.
- Get familiar and with company and department SOP and working procedures -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- Timely accomplishment of assigned tasks in required quality.
- Compliance with regulations and internal procedures -Relevant databases and archives up -to -date.
Minimum Requirements:
Work Experience:
- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
Skills:
- Clinical Trials.
- Collaboration.
- Databases.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.
Languages :
Skills Desired
Clinical Trials, Collaboration, Detail-Oriented, Project Planning, Regulatory Compliance