A senior regulatory professional with over 25 years of experience in the development of biopharmaceutical products.
Global CMC and non-clinical regulatory expertise in Biologics development, approval and life-cycle maintenance. Familiar with worldwide regulations and guidelines, including managing regulatory interactions with agencies.
Expertise
- Scientific Expertise: Protein Engineering, Molecular Biology, Protein Biochemistry, Cell Biology, Immunology and Vaccine manufacturing & testing
- Modalities: vaccines, therapeutic recombinant proteins, cell banks and viral vectors, . antibodies, mRNA-based products, cell & gene therapy and medical devices
- CMC Regulatory Expertise spans across the whole product life-cycle. Has contributed to the development and licensing of several vaccines (e.g. Cervarix, H1N1 pandemic Flu vaccine, quadrivalent seasonal Flu vaccine, Shingrix) as well as worldwide license maintenance of the entire GSK vaccines portfolio (N = 25+ products)
- 100+ CMC variations per year
- Regulatory body interactions include: FDA, EMA, PMDA, Korea MFDS
- Extended expertise with US and EU requirements
- Non-clinical Regulatory Expertise: Authoring non-clinical M4, M2.4 and M2.6 e-CTD sections of Cervarix vaccine
- Management of Change Control Process and Quality Systems: release process, deviations & corrective and preventive actions, including regulatory inspections (FDA, EMA, Japan, Canada, etc.)
