Requisition ID: WD91860
Basic qualifications:Bachelor of Pharmacy degree/ BSc Biological SciencesPreferred qualifications:PharmD, PhD MBA, MSc, will be desirableDetails:JOB PURPOSETo support the Head of Regulatory in the implementation of agreed regulatory strategy as it relates to registered products life cycle maintenance and NCEs/NPDs and Branded generics registration in the marketWork with the RAD to simplify and improve existing regulatory processes, systems and techniques to enhance capability of Regulatory ExecutivesKEY RESPONSIBILITIES:
Regulatory Due Diligence for successful NCEs/NPDs/PREPs registration
Clinical Trials Submissions and Tracking with Regulatory Agencies
OPAL Champion for (maintains updates and correctness of all approved products databases and Variations)
Supervision of the REs to ensure deliverables are met yearly
Agile MLCC for all products
IPI and PSUR updates handling
Registered products Regulatory Databases maintenance /compliance
Support the RAD in Regulatory Governance/Conformance Activities. E.g Project Edge Labelling
Provide regulatory support as and when required for special projects
Interphase with the Africa Regulatory Hub team on life cycle management processes
External facing with Regulatory Agencies as back up for the Regulatory Affairs Director
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