Regulatory Affairs Associate

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 :

• English.

 

Skills Desired

Clinical Trials, Collaboration, Detail-Oriented, Project Planning, Regulatory Compliance