Ashley Makondo

Experience

• 

  Aspen Pharma Group

  Oct 2016 - Jan 2017

  Regulatory Affairs Compliance Intern
• 

  Adcock Ingram Critical Care (Pty) Ltd.

  Feb 2017 - Nov 2021

  Category A & D Medicines and Medical Devices- Under the supervision of a portfolio leadNew Registrations- Perform due diligence (DD) on new products, additions to the line and new indications required for registrations as per the Health Authority (HA) requirements, within the allocated timeframe. - Compile a deficiency list and submit to the principal to request additional information.- Arrange a teleconference with the principal to discuss the deficiencies in the dossier and timelines to provide the documents- Assess the product for expedited review application and if relevant submit the expedited review application.- Compile the Professional Information (PI), Patient Information Leaflet (PIL) and label and submit to medical for review and approval within the required timelines- Compile Module 1 to 5 of the CTD for filing within the allocated timeline.- Check and ensure the quality of the submission and all documents have been included as per the screening checklist before submitting to the HA- Responsible for follow up with the HA on the submissions.- Respond to HA committee recommendations within the required timeframe and ensure that the recommendation responses are placed on file and old information superseded- Get involved in the launch preparations of new products providing regulatory supportAmendments/Product life cycle management- Address or raise a change control for changes relating to products in my portfolio- Perform DD and ensure that all documents required as per the amendment guidelines have been received.- Check and ensure the quality of the submission and all documents have been included as per the amendment guidelines.- Respond to recommendations if any within the shortest time frame to ensure compliance and out of stock situations.- Inform the relevant parties on the implementation of the amendment.- Ensure that amendments are placed on file and the old information is superseded Show less 1. Collecting, collating and evaluating scientific data into the electronic database (docuBridge) for inclusion in regulatory applications. 2. Manage technical and scientific regulatory activities as defined in the department. 3. Develop and/ or facilitate processes and standards relating to compiling and publishing deliverables of the department. 4. Maintenance of the scientific database available to the Regulatory team. 5. Work with Head of RA and RA team to implement update processes and/or standards for electronic database and submission criteria. 6. Ensure that Submission Operations’ requirements are identified and correct measures implemented.7. Artwork – ensure 100% compliant to dossier text, any deviations noted and cleared with Management.8. Successful and timeous implementation of amendment by customers and update of dossiers9. Manage all aspects of the submissions of new product application for the Hospital Business Units in specified territories and RSA Show less

  • Regulatory Affairs Scientist

    Apr 2017 - Nov 2021

  • Regulatory Affairs Scientist Graduate

    Feb 2017 - Apr 2017
• 

  Novartis

  Nov 2021 - Apr 2022

  Regulatory Affairs Associate
• 

  Adcock Ingram

  Apr 2022 - now

  • RA Portfolio Lead - Medical Devices and Pharmaceuticals

    Apr 2023 - now

  • RA Senior Associate/RA Ops Lead

    Apr 2022 - now