Regulatory and Quality Assurance Trainee - Roche

Roche Diagnostics in Accra is seeking a Regulatory and Quality Assurance Trainee to support the implementation and ongoing management of regulatory activities, regulatory submissions and associated activities to ensure the rapid and optimal registration of new Diagnostics products and Lifecycle Management of registered products within the West African region.

The successful candidate will also provide support to the global temperature monitoring program within the region.

Key Responsibilities will include amongst others:

Regulatory Submissions

• Support regulatory activity priorities and the timing for such

• Assist in implementing regulatory activities according to the regulatory strategy to achieve the best business outcomes for Roche Diagnostics West Africa
• Support regulatory submissions and circulating for additional internal reviews according to legislative and regulatory requirements, local, Operating Procedures (SOPs)
• Support in timely submission of final regulatory applications to health authorities in the West Africa region
• Support regulatory activities across various areas to ensure that they are consistently completed and executed in full compliance with Roche SOPs, legislative and regulatory requirements

Regulatory Compliance

• Support ensuring that reference standards and GMP clearances are obtained in a timely manner
• Support the management of import/export licensing requirements
• Ensure that current regulatory certifications, licenses and other permits are in place

Post Market Surveillance

• Support product notifications (safety board notifications and quality notifications) by identifying customers affected by the notifications, communicating the notification details, facilitating that corrective action is implemented and providing feedback to the Safety Board as required

Global Temperature Monitoring and Administration

• Validate shipment compliance with the global temperature monitoring requirements by receiving data, analysing information, identifying areas of non-compliance and referring areas of concern for corrective action weekly and as required
• Review consignment compliance data by receiving reports, analysing compliance with key parameters, identifying anomalies, investigating reasons for anomalies, providing feedback and supporting the implementation of corrective action as required

Other

• Support in the development and maintenance of regulatory resource documents. Includes SOPs, working instructions, etc
• Ensuring that all work instructions and other regulatory information are current and accurate
• Updating Regulatory Affairs systems with current regulatory activities, timelines and priorities. Including electronic and hard copy filings, product information submitted to health authority websites, Roche intranet and internet sites
• Ensuring internal cross-functional teams are provided with current product registration details and other relevant information
• Ensures appropriate support and assistance for internal/external audits

You, as an ideal candidate, will have the following skills, experience and education:

• We are seeking a candidate with a Bachelor’s degree in Pharmacy, Biological or Medical Sciences, Industrial Engineering or similar. Please submit a cover letter motivating your application as well as your academic transcripts/results