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Regulatory Pharmacist

GlaxoSmithKline
Nairobi, Kenya

Salary rangeConfidential | Contract type: Permanent

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Job Summary

Business growth through new products registrations and maintaining the registrations (license renewals/license validity and lifecycle management) on an ongoing basis in the assigned country/region, thus ensuring continuity of supply and regulatory conformance to all applicable laws and guidelines.
To ensure that any other applicable licenses, e.g. Wholesale licenses and Medical representative permits are issued by the regulators.
To ensure QMS objectives for the assigned country/region are met.

Responsibilities

• 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

Job Requirements

Required education: Bachelor's degree
Required relevant work experience: 2 years
Required languages: English (Spoken: fluent | Written: fluent)
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