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:
• Ensure registration master file update
• Coordinate and prepare high quality submissions of regulatory dossiers for assigned products
• Timely update and communicate the registration status to the line manager
• Achieve the CTA/NDA submission and approval on the targeted date;
• Ensure license renewal submission and approval on time;
• Communicate the questions referred by HAs timely and smoothly;
• Timely order and tracking the registration sample, dossier, certificate
• Ensure CMC/BPI/PSUR/RMP in line with NMPA regulation and Novartis internal policies;

• Experience in Regulatory Affairs role in pharmaceutical industry
• High-level understanding of Regulatory quality, standards and policies.
• Attention to detail and quality focused
• Fluent in Vietnamese and English
• Bachelors/ Masters Degree in Pharmacy
You can apply to the job via our official careers website here: https://www.novartis.com/careers/career-search/job-details/325689BR
Please note that this role is based in Hanoi.

Competitive Benefits

Cập nhật gần nhất lúc: 2021-09-08 06:13:02