Work with NGOs Starting Salary- Ksh 200k
- To compile and submit registration dossiers in accordance with the country specific requirements to relevant Regulatory Authorities in East Africa.
- Dossier Maintenance: Submission of post registration variations in line with country specific regulatory requirements
- Submission of updated product Package insert or labeling updates in line with country specific requirements and in line with the internal GSK requirements.
- To maintain the relevant Global and local Regulatory and compliance databases
- To align regulatory product registration submission strategy to commercial product strategy
- Manage and develop strategies that overcome regulatory challenges for new product registrations and line extensions
- Review of promotional materials to ensure adherence to country specific requirements
- A University graduate with Bachelor of Pharmacy or Science based degree or equivalent
- Work experience of 2-5 years in pharmaceutical regulatory environment
- Good interpersonal skills, high integrity and ability to engage in ethical conversations are a pre-requisite
- Excellent communication skills
Knowledge and experience of Regulatory Affairs in markets in Eastern Africa
- Lobby and network with Regulatory Authorities for fast track approval of GSK products.
- Provide regulatory support/training to stakeholders as appropriate
- Ability to work well under pressure and still maintain sound balance in decision making.
- Ability to meet the deadlines for the strategic and tactical plans.
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