Purpose

• To support the RA Team in registration of new drug products and the maintenance of registration of approved drug products to ensure patients have access to our products ...l.as well as maintain DRAGON and other databases to ensure up to 95% compliance level.
• To implement RA specific process/quality standards as well as ensuring that the regulatory databases are up to date and accurate with regulatory relevant parameters throughout development, registration and approval (including post approval commitments and license maintenance).
• To support the RA team in the performance management and tracking of quality assessments and rapidly addressing compliance related issues
• To support the East Africa RA Team in submission and tracking of labelling and related activities for all registered products.

Major Accountabilities

• New Product Registrations: Support the RA Team by preparing local dossiers for submission of drug registration applications in a timely manner and follow up of the application during the evaluation phase to achieve a favorable outcome
• Maintenance of registered products: Support the RA Team in maintaining registration of currently approved products
• Maintaining DRAGON and other relevant databases with up to date and accurate information of the products under the supervision of the RA Managers.
• Relationship with Distributors: Under minimal supervision, ensures that all registration documents necessary for the importation of products are provided to our distributors to ensure compliance.
• Relationships outside the company: Develop and maintain good working relationships with Health Authority and LTR in country of responsibility.
• Provide feedback from Health Authority to the RA Team while following up on submissions made to the Health Authority.
• Handle any additional tasks provided by the RA Managers
• Support the RA Compliance Associate in cluster self-assessment and audit readiness activities as required
• Support data consistency management and CCEx activities
• Support the RA Compliance Associate in the process QC by reviewing related records against requirements of SOP and/or regulations to assess the process compliance status. Ensure compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
• Contribute to labeling management and continuous improvement initiatives, review and comment on emerging regulatory labeling guidelines
• Support the maintenance of Country specific presentations as applicable

Requirements

Ideal Background

• Education (minimum/desirable): B. Pharm or BSc in life sciences
• Languages: Fluent in English (mandatory)
• Experience: Minimum 1 year RA experience
• Good communication and negotiation skills. Good inter-personal skills.
• Good understanding of the regulatory landscape in East African Countries preferably in Ethiopia and Sudan
• Detail-oriented and organized
• Good understanding of CTD dossier format