We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Regulatory Information Management Specialist
- All data entry and remediation activities in Regulatory systems, mainly
- Document Management System (DMS)
- Regulatory Information Management System (RIMS)
- eCTD Publishing System
- Support data extract, clean-up, and migration mapping activities
- Contribute to data entry guides as well as data consistency and integrity checks and make recommendations for improvement
- Routine configuration tasks: picklists, templates, users
- Maintenance of system meta data and attributes
- Contribute to automation of system-related tasks
- Perform test activities in the context of Computer System Validation (under supervision)
- Prepare metrics reports for projects: documents authored, dossiers dispatched, PV updates (xevmpd), license updates (registrations)
- Basic experience and knowledge in the field of Regulatory Affairs, Regulatory Operations, or related field
- Basic understanding of regulatory landscape, esp. in regards of systems, standards and related processes
- Attention to detail, methodical, accurate at speed, quality driven
- Knowledge about IT systems and databases as well as related technologies
- Drives solutions to complex problems impacting company success
- Analytical and structured thinking as well as accurate and thorough working
- Ability to work in large international and/or complex project teams
- Support achievement of project milestone
- Ability to adjust rapidly to new, unknown, challenging situations
- Ability for self-reflection and provides the required professional attitude
- English language business fluency
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.