Regulatory Affairs Records and Data Manager
An exciting opportunity has arisen for a Regulatory Affairs Records and Data Manager at a pharmaceutical company in Zurich. The bright individual will be able to step up and grow organically within the company which is perfect for an individual who is looking for a career development.
- Act as owner and primary author for all Global Regulatory Affairs (GRA) records management related policies, SOPs and work instructions
- Provide training for staff in relevant Vifor processes, procedures and tools, including specific training and advice to GRA staff for OpenText Content Server (eDMS) application and associated tools
- Lead selected records management initiatives (within GRA or cross-functional)
- Chair relevant intra-departmental teams governing departmental systems document management and regulatory information management
- Conducting departmental records management audits and providing compliance/audit support
- Partner with department staff to resolve document discrepancies and to correct data issues in GRA systems
- Provide records management KPI reporting
- Support QA in hosting and responding to external audits and inspections, and presenting information relative to GRA
- Participate in cross-functional training groups (eDMS, RIMS, e-Archiving initiative, interdepartmental authoring processes)
- Provide regulatory input into the development and maintenance of global records retention schedules to ensure corporate policies and standards are consistent with Swiss, EU and global regulatory requirements
Skills and Requirements
- Bachelor's degree or equivalent required
- Previous employment in Records Management
- Expertise with Electronic Document Management Systems (eDMS) such as OpenText, Documentum, MS SharePoint, etc.
- Minimum 5 years relevant work experience in a regulated industry (e.g. pharmaceuticals, medical devices, insurance, financial services, transportation or government administration)
- Experience with analysis of data, file structures, format transformations, and data mapping
- Expertise with common standards such as ISO 15489, ISO 23081, MOREQ2010 or Swiss, US or EU Member State federal standards
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
A full job description is available on request.