Regulatory CMC

My most recent positions, as a CMC Regulatory Senior Specialist, Regulatory Submission and CMC Coordinator I managed compliance projects, coordinated submissions and CMC activities. I consider myself to be detail, analytical and technical orientated.

• Projektmanagement

A Microbiologist by training with over 25 years of experience in the pharmaceutical and medical technology industries. I started my career in a medical laboratory at the South African Institute for Medical Research. Subsequently I joined a Pharmaceutical production company and worked myself up to a QA Microbiology Manager. In 1999 I moved to Switzerland where I worked for a Central Laboratory managing client’s projects, proposals and budgets in a clinical trial environment. In my most recent position, as a CMC Regulatory Senior Specialist I managed compliance Projects and coordinated a BLA Regulatory Submission. I consider myself to be detail, analytical and technical orientated, a strong team player and a passionate desire to excel against demanding expectations. I have proven ability to project manage, identify process improvement needs, develop and put in place new processes to streamline workflow.

Microbiology Technician - South African Medical and Dental Council
Quality Assurance - City and Guilds of London Institute
Project Coordinator
Project Manager
ISO 9001
GMP GLP
Regulatory CMC
Quality Assurance
IT savvy