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.