Description
We are looking for a
Senior Global Technical Regulatory Business Administrator (m/f)
Reference: -en
Start: 03/18
Duration: 9 MM
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Provide first line support for DRA end users and information to 2nd level support, create Service Request & Incidence reports, User Management
- Manage administration of and provide support for DRA owned computerized systems, including but not limited to Documentum (DRAShare), DRAWA file share, RSS (eCTDXPress &ISIPublisher), other ISI software (Toolbox), Rosetta Phoenix, DRAGON
- Key support role in the finalization and timely availability of submissions to CPOs and health authorities
- Investigate incidences and provide root cause analysis
- Summarize activities for reporting to management
- Liaise with DRA Operations Global Head Standards & Strategy on matters regarding changing regulatory requirements and the related business processes
- Participate in validation and implementation activities for system upgrades and functionality enhancements
- Provide user training for DRA end users
Your qualifications
- Bachelor's degree in computer science or business management, preferably with profound experience working with document management systems or publishing software used in the pharmaceutical industry
- Previous working experience with a ticketing / remedy system
- Good understanding of validation
- Experience with eCTD and XML technology would be an advantage
- Very good knowledge of English, written and spoken
- Good interpersonal skills, with an ability to effectively manage customer relationships with internal and external partners
- Knowledge and experience with eCTD submissions as well as advanced knowledge of xml is highly desirable
- Training and experience in 21 CFR Part 11 requirements for electronic records, electronic signatures
- Good knowledge of the different Health Authority submission formats, the overall drug development process, and the related document requirements
- Ability to run a small project team
Skills:
- Regulatory affairs assistant