Terri-Anne Terblanche

Experience

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  MigrationWare

  Jan 2001 - Dec 2002

  Office Manager
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  Progressive Housing Investments

  Jul 2003 - Mar 2006

  Secretary / Residential Letting Assistant
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  Workman LLP

  Aug 2006 - Dec 2017

  Team Secretary - Building Surveying
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  Takeda

  Dec 2017 - Dec 2019

  Snr Admin Assistant - Global Regulatory Affairs

  Achievement: Consolidate Health Authority Certification / Module 1 documents requests into a single point of contact to support a more efficient / streamlined service to LOCs globally.Admin support to the International Regulatory Strategy Team (including the Head of International Strategy) and the coordination of Regulatory Certificates for submissions.Full EA/Admin Support: Support the Regulatory Strategy Team and the wider Global Regulatory Affairs department within the London, Austrian and Swiss office.Diary Management: for the Head of International Regulatory Affairs and the wider team.Meeting Coordination: both locally and globally, including team and department meetings and team off-sites.Events Coordination: including in-house training sessions, social events and scientific advice meetings with EU Health Authorities (across the EU).Finance: duties included purchase order management for both external vendors and internal contractors within SAP and Coupa including PO creation, invoice processing and receipting, PO extensions, invoice approvals and PO closures.Expenses Management: for the Head of Department through Concur.Travel Management: for both the Head of Department and group bookings for the team (international flights, accommodation and airport transfers).Vendor Management (Source and Onboard): including consular/legalisation vendors, in- house training providers, hotels, caterers and event speakers.Global Legalisation Requests: first point of contact for all legalisation requirements globally.CPP Requests: first point of contact for any CPP requests globally which includes cross functional liaison with Product Leads, Reg CMC Leads and Heath Authorities.Staff Training: on company systems and processes (i.e. SAP/Coupa, Concur, CPP and legalisation processes, etc.). Show less

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  ICON plc

  Jan 2020 - Aug 2023

  Achievements: Automation of Health Authority Certification / Module 1 documents request process and tracking system to ensure a more efficient, stable and transparent system globally, including metrics for Client reporting and data cleansing prior to migration. Furthermore, during the COVID-19 lock-down, I arranged company wide social event (online) to bring together our colleagues during a time of mandatory isolation, to support my colleagues and foster cross functional team collaboration during this difficult time.Document Coordination: Tracking and monitoring of Module 1 document requests, including quality checks to ensure accuracy in a time efficient manner. Coordination of Certificates of Pharmaceutical Products (CPP) requests globally, ensuring clear communication with cross functional stakeholder groups to identify local requirements. Draft/submission of CPP applications to relevant Health Authorities, including continual liaison with the Health Authorities through to completion of application. Health Authorities include MHRA, HPRA, EMA, FDA, FAMHP and DKMA. Coordination of Certificates of Good Manufacturing Practices (GMP) and Manufacturing Licences (ML) requests from Eudra website and, where necessary, undertaking applications for original GMPs and MLs from FAMHP. Coordinating signature requests for ancillary documentation globally.Onboarding/Mentoring: Provide training to all new team members, to include IT systems, processes, Health Authority requirements, etc. Provide training to new employees of our existing Clients, to include internal processes, tracking and processing requests and Health Authority requirements. Processes, Policies And Improvements: Review and monitor current processes to identify process improvements and implement as required. Provide guidance and training to all Clients, team members and third party vendors on any implemented process improvements. Ensuring all processes and policies are understood and complied with. Show less

  • Regulatory Affairs Consultant

    Apr 2023 - Aug 2023

  • Regulatory Publishing Specialist

    Jan 2020 - Mar 2023
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  CDN Consular Services Ltd

  Jan 2024 - Jan 2024

  Regulatory Affairs Consultant / Submissions Specialist

  General consulting service to include:- High level overview of submission processes for EU and US with a particular interest in Module 1 documents and coordination of these documents.- Review of current certificate ordering processes and advising efficiencies.- Review of in house order tracking system and advising potential upgrades.- Review of Company Brochures and assist with updating/refreshing information and services offered.- Training submission colleagues on the processes of applying for Regulatory Certificates from FDA, Austria (AGES_BASG), Belgium (FAMHP), Denmark (DKMA), Germany, Italy (AIFA) and Sweden (MPA). Show less

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  Cytel

  May 2024 - now

  Project Associate