Beschreibung
RA Specialist (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM+
Main tasks:
- Responsible for execution of local RA processes and activities in alignment with RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation
- Assist in timely preparation, submission of new Marketing Authorization Applications to local Health
- Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards
- Files, stores, updates and archives regulatory data and documentation in accordance with department and company policies and local requirements
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues
Main qualifications
- Health, life science, or medical science degree or equivalent by education
- Industry experience in regulatory affairs
- General knowledge in RA regulations within his/her assigned country and be an expert in RA processes/activities
- Good communication and time management skills
- Fluent in English and German
Main advantages:
- Workload: 50 %
About us:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in 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 experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
My contact at Hays:
My contact person:
Chiara Milan
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