This role provides effective operational and regulatory support to the company 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. The person coordinates and prepares high quality submissions of regulatory dossiers for assigned products - Achieves the CTA/NDA submission on the targeted date, achieves the approval of CTA, NDA and other related supplementary application on the targeted date. The candidate ensures license renewal aubmission and approval on time, registration master file update and assists to coordinate f2f meeting with CFDA/CDE for new project discussion etc.
Drug Regulatory Affairs Coordinator
Global Pharma Company
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!
Bachelors or Masters in Science
As per industry
3-4 years relevant experience in the area of regulatory affairs is needed. The candidate should have experience with preparing high quality submissions of regulatory dossiers for assigned products to Swissmedic in time and experience with regulatory maintenance activities: CMC variation, renewals and additionally assigned tasks (e.g. variations, safety updates, annual reports, risk minimization documents).
Deutsch: Sehr gut
Englisch: Sehr gut
If you are interested then kindly send your resume to firstname.lastname@example.org