The Position
Supporting the implementation and ongoing management of regulatory activities, regulatory submissions, and associated activities to ensure the rapid and optimal registration for new Diagnostics products and Lifecycle Management of registered products within the East African region.
Role and Responsibilities
Regulatory Submissions
To support regulatory submissions and post-approval activities, to ensure timely applications to health authorities in the East Africa region
To support regulatory activities across CPS, RTD, and RMD areas are consistently completed and executed in full compliance with Roche SOPs, legislative and regulatory requirements
Timely, accurate and compliant regulatory documentation, systems and procedures: Update Regulatory Affairs systems with current regulatory activities, timelines and priorities. Includes electronic and hard copy filings, product information submitted to health authority websites, Roche intranet and internet sites
Stakeholder management: Internal cross-functional teams are provided with current product registration details and other relevant information
Regulatory Compliance
To support the management of import/export licensing requirements.
Ensures current regulatory certifications, licenses and other permits are in place as may be required
To support development and maintenance of regulatory resource documents. Includes SOPs, work instructions, etc.
Global Temperature Monitoring and Administration
To validate inbound shipment compliance with the global temperature monitoring requirements by receiving data, analyzing information, identifying areas of non-compliance and referring areas of concern for corrective action weekly and as required
To review consignment compliance data by receiving reports, analyze compliance with key parameters, identify anomalies, investigate reasons for anomalies, provide feedback and support implementation of corrective action as required
Qualifications and Education Requirements
Bachelor’s degree in Pharmacy, biological or medical sciences, industrial engineering or similar is required
Registered with PPB/applicable Board where necessary
Accuracy and attention to details
Customer service skills
Analytical and problem solving
Communication (verbal and written)
Organisational skills and time management
Planning, organising and prioritising
Cross-functional team skills
Motivated and self-driven
Apply via :
careers.roche.com
