Regulatory Affairs Coordinator 18 months contract
Posted on Mar 17, 2021 by Michael Bailey Associates - Zurich
We have an interesting project for an emerging Regulatory affairs professional to join a team to support Regulatory affairs projects in activities, including preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities.
-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 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;
-Provide regulatory support for other functions(marketing, medical, sales, MA&C, TechOps);
-Start to establish good communication and relationship with key stake holders.
-Get familiar and with company and department SOP and working procedures
Prior experience in a regulatory affairs function in the pharmaceutical industry
Knowledge of electronic tool for submission
Knowledge of documents and reports required for local and global submission
Excellent communication skills
Fluency in German and English is required
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.