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.
go to method of application »
Use the link(s) below to apply on company website.
Apply via :
