Drug Regulatory Affairs Coordinator

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.

  • Chemie
  • Zug
  • Vollzeit
  • Temporär

Firmenprofil

Global Pharma Company

Arbeitsort

Zug

Arbeitsbeginn

July 2021

Motivation

Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!

Ausbildung

Bachelors or Masters in Science

Salärrahmen

As per industry

Erfahrungen

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).

Alter

Open

Sprachen

Deutsch: Sehr gut
Englisch: Sehr gut

Spezielles

If you are interested then kindly send your resume to v.agarwal@universal-job.ch

Vakanz-Nummer

P-13-7070

Personalberaterin

Vasudha Agarwal
Universal-Job AG
Kasinostrasse 32
5000 Aarau
Vasudha Agarwal Mail +41 62 834 63 58 V-Card
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