I am a regulatory affairs professional with over 10 years of experience across CRO, sponsor, medical device, and consulting environments. I independently author and manage complex clinical trial applications, amendments, and notifications to MCC/SAHPRA and ethics committees across multiple concurrent studies, including oncology trials, while serving as a country-level regulatory contact for sponsors, investigators, ethics committees, and authorities. I also bring five years of experience supporting EU MDR and FDA submissions for Class IIb oncology devices, including authoring Clinical Evaluation Reports and State-of-the-Art sections during the MDD-to-MDR transition. I combine strong regulatory intelligence, evidence synthesis, document review, project coordination, and stakeholder communication skills, and I am comfortable working in fast-paced, deadline-driven, multicultural environments.
Experience
Principal Regulatory Affairs & Compliance Consultant
Sager Regulatory ConsultingJan 2025 – Present
I conduct systematic literature reviews and evidence synthesis for Clinical Evaluation Reports, critically assessing whether clinical claims are supported by the underlying evidence. I develop and review regulatory and quality documentation, prepare defensible gap assessments, support post-market surveillance and vigilance activities, and provide pharmacovigilance support and regulatory intelligence monitoring for pharmaceutical and medical device clients.
Regulatory Affairs Specialist
NovocureJan 2019 – Jan 2024
I authored Clinical Evaluation Report and State-of-the-Art sections for two Class IIb devices during the MDD-to-MDR transition, critically reviewing and synthesising clinical and scientific evidence. I supported FDA PMA programmes and EU MDR Notified Body submissions, maintained regulatory documentation for submissions and lifecycle management, conducted regulatory intelligence impact assessments, and collaborated with global Regulatory Affairs, Clinical Operations, Quality, Safety, and Manufacturing teams.
Research Director / Regulatory Consultant
Sager Research ConsultingJan 2017 – Jan 2019
I produced evidence-based reports and regulatory assessments for healthcare stakeholders, synthesising complex scientific information into clear written deliverables. I also supported ethics approvals, protocol review, and clinical research governance activities.
Country Approval Specialist
PPD InternationalJan 2016 – Jan 2017
I independently authored and managed Clinical Trial Applications, amendments, and notifications to MCC/SAHPRA and Ethics Committees/IRBs across multiple concurrent studies, including oncology trials. I interpreted protocols, Investigator Brochures, and informed consent documents, reconciled inconsistencies before submission, and responded to authority and ethics committee queries affecting study approvals.
Independent Contractor
Various Sponsors & CROsJan 2014 – Jan 2016
I provided freelance regulatory affairs and clinical trial coordination support to sponsors and CROs, including submissions to regulatory authorities and ethics committees.
Clinical Trial Specialist
PAREXELJan 2013 – Jan 2014
I prepared and coordinated regulatory authority and ethics committee submissions, maintained clinical and regulatory documentation, and supported inspection readiness.
Clinical Trial Coordinator (Regulatory)
ClinTec International / MSDJan 2012 – Jan 2013
I managed regulatory submissions and correspondence with MCC/SAHPRA and ethics committees for the sponsor across multiple concurrent studies.
Education
Post Graduate Certificate in Education (PGCE)
2005 – 2005
Bachelor of Social Sciences (Psychology), Psychology
2002 – 2004
Deans Merit List
Skills
Languages
- English
- Native or bilingual proficiency
- Afrikaans
- Limited working proficiency