Summary
About the Role
- 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)
- Timely accomplishment of assigned tasks in required quality.
- Compliance with regulations and internal procedures -Relevant databases and archives up -to -date.
Work Experience:
- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
- Clinical Trials.
- Collaboration.
- Databases.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.
- English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
