Our product portfolio also includes a range of consumer brands, many of which are household names around the world, including Sensodyne, Aquafresh, Horlicks, Panadol and Tums.
Job Title: Regulatory Affairs Manager
- To 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 market
- Work with the RAD to simplify and improve existing regulatory processes, systems and techniques to enhance capability of Regulatory Executives
- 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 deliverable 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 Labeling
- Provide regulatory support as and when required for special projects
- Inter-phase with the Africa Regulatory Hub team on life cycle management processes
- External facing with Regulatory Agencies as back up for the Regulatory Affairs Director
- Bachelor of Pharmacy degree/ BSc Biological Sciences
- PharmD, PhD MBA, MSc, will be desirable
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