Latest Jobs at CDL Human Resource

Job Purpose

• Registration of new drug products and maintenance of approved drug licenses to ensure availability of these products in the countries.
• Maintain good relationship with the HA to enhance prompt registration of new products and maintenance of product licenses. 
• Maintain all necessary organization databases (e.g. DRAGON) to always ensure regulatory compliance.
• Maintain open communication with the different stakeholders and regularly provide information when required.
• Liaison between different stakeholders on regulatory matters.

Major Accountabilities

• To support the planning and co-ordination of submission of drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve approval in line with planned registration timelines.
• To ensure (through follow up) that documents for new registration and re­registration are requested and received to ensure submission is achieved by due dates
• To ensure that submissions for license renewal are done in good time before license expiry to achieve approvals and to avoid Top line impact due to license expiry
• To ensure submissions for production transfers and pack size extension are made and approvals received by due dates
• To apply for and get approvals for pre-license promotion through named patient basis or orphan drugs when required.
• Ensure compliance to current local regulations and communication of any changes that may impact our organization in a timely manner to all relevant Stakeholders.
• Support the update local/Regional Working Practices or SOPs when required.
• Ensure adherence to Global and local/regional processes.
• Ensure prompt submission of post approval commitments, PSUR submissions, RMP submissions, SLC updates and ensure timely responses to HA as required.
• Ensure issues of non-compliance are handled with urgency and appropriate channels are engaged in a timely manner when necessary
• Ensure compliance to global and local KPIs.
• Review and approval of marketing promotional materials when assigned by RA Head
• Develop and maintain good working relationships with other organizations functions/departments both locally and globally, as well as with health authority, local technical representatives and industry bodies.
• Support our LTRs and distributors on regulatory issues as assigned by RA Head
• Support the organization culture including promotion of diverse and inclusive environment, free from all forms of discrimination and harassment

Requirements

Ideal Background

• Education (minimum/desirable): B. Pharm or BSc 
• Languages: Fluent in English (mandatory)
• Experience: Minimum 3-5 years regulatory and drug/biologics development experience.
• Health Authority experience desirable in Ethiopia and Sudan
• Good communication and negotiation skills.
• Good inter-personal skills.

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Job 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