Regulatory Submission Coordinator (m/f/d)

Bern  ‐ Vor Ort
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Beschreibung



Regulatory Submission Coordinator (m/f/d)

Reference: -en
Start: asap
Duration: 6 MM+

Main tasks:
  • Perform submission coordination as defined in the Global Submission Management Process
  • Coordinate the submission of major changes in all regions in close collaboration with the submission team and submission owner
  • Lead and document relevant outcome of submission team meetings
  • Receive regional or country specific documentation requirements from the Regional / Local Regulatory Representative
  • Create, in collaboration with Regional / Local Regulatory Representative(s) and Document Coordinator(s), the Submission Content Plan (SCP)
  • Request and track submission documents
  • Coordinate the submission package assembly, create publishing requests and reviews (QC) published outputs, if applicable
  • Ensure timely submission by collaborating with Regional / Local Regulatory Representative(s)
  • Ensure timely tracking of relevant submission information


Main qualifications
  • Regulatory or submission coordination experience preferable
  • Experience in Regulatory Affairs (incl. hands-on experience with submissions)
  • Strong organizational skills, good communication skills (ability to share information, reinforce timelines, advocate the new processes and roles), readiness of mind
  • Effective use of modern technology (MS SharePoint and Excel, Skype for Business)


Main advantages:
  • A very renowned company



About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

My contact at Hays:

My contact person:
Yves Fabien Deschamps

Referencenumber:


Make contact:
Email:
Start
ab sofort
Dauer
6 MM+
(Verlängerung möglich)
Von
Hays AG
Eingestellt
14.09.2019
Ansprechpartner:
Kerstin Werner
Projekt-ID:
1823204
Vertragsart
Freiberuflich
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