Regulatory and Quality Assurance Trainee at Roche Kenya

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