Drug Regulatory Affairs Officer

As Regulatory Affairs Officer, you will provide effective operational and regulatory support to Sandoz as well as to regional/global organizations for assigned regulatory submission and maintenance activities. Apply now to become a part of our dynamic team!



Your responsibilities include, but not limited to:

• Coordinate and prepare high quality submissions of regulatory dossiers for assigned products

• Achieve the CTA/NDA submission and approval 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

• 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, certificate