Beschreibung
GRA Submission Coordinator (m/f/d)
Reference: -en
Start: 02/22
Duration: 12 MM
Main tasks:
- Perform submission coordination as defined in the Global Submission Management Process
- Coordinates the submission of major changes in all regions in close collaboration with the submission team and submission owner
- Leading and documenting relevant outcome of submission team meetings
- Receives regional or country specific documentation requirements from the Regional / Local Regulatory Representative
- Creates, in collaboration with Regional / Local Regulatory Representative(s) and Document Coordinator(s), the Submission Content Plan (SCP)
- Requests and tracks submission documents
- Coordinates the submission package assembly, creates publishing requests and reviews (QC) published outputs, if applicable
- Ensures timely submission by collaborating with Regional / Local Regulatory Representative(s)
- Ensures timely tracking of relevant submission information
Main qualifications
- Regulatory or submission coordination experience preferable
- 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 regulatory systems (i.e. RIMS, EDMS) and Microsoft 365 applications
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:
Marc Peter Linder
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