Roche Kenya Regulatory and Quality Assurance Trainee Jobs in Kenya

Roche Kenya Regulatory and Quality Assurance Trainee Jobs in 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.

How to Apply

For more information and job application details, see; Roche Kenya Regulatory and Quality Assurance Trainee Jobs in Kenya

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