Job purpose
- Maintain applicable regulatory affairs information management electronic systems, ensuring accurate system usage and data integrity by all stakeholders.
- Ensure accurate and timeous system administration.
- Create, review and maintain accurate data in company electronic regulatory affairs information management system(s)
- Interpret, record and action Regulatory Authority correspondence accordingly in applicable electronic regulatory affairs system(s)
- Development, implementation, training and maintenance of the procedures and processes
- Data analysis and report generation for the company Business
- Provide support to cross-functional departments
- Establishes and maintains relationships with stakeholders and vendors
- Manage the Regulatory Helpdesk by resolving queries within agreed timelines
- Work in close collaboration with the IT department on upgrades, back ups and support of the RA electronic operating systems and ensure relevant actions are timeously updated
- Ensure good document practice is maintained in the department.
- Partake in internal and external audits, as required
- Provide applicant admin support
