Highly accomplished and dedicated senior regulatory professional with more than 25 years of experience in research and development of biotechnical products in the pharmaceutical industry, supported by 10 years hands on scientific knowledge acquired as a Researcher in several Public Institutions in Protein Engineering.
Demonstrated global CMC and non-clinical regulatory expertise in Biologics development, approval and life-cycle maintenance. Familiar with worldwide regulatory constraints and evolving environment, including knowledge of relevant global regulations and guidelines and interaction with Authorities.
With more than 15 years of experience in Team management, developed empowering and inclusive approach for leading diverse and remotely located regulatory Teams (up to 120 people).Experienced at building and leading high performing teams, including managing departmental budget and human resource. Comfortable working in a changing environment, dealing with unfamiliar situations.
Expertise
- Scientific Expertise: Protein Engineering, Molecular Biology, Protein Biochemistry, Cell Biology in the field of Microbiology, Immunology and Vaccine manufacturing & testing.
- Products Expertise: deep knowledge with vaccines, therapeutic recombinant proteins, cell bank and viral vectors. Good knowledge with antibodies, mRNA-based products, cell & gene therapy and medical devices.
- CMC Regulatory Expertise spanning all product life-cycle stages: Specifically contributed to the development and licensing of several vaccines (e.g. Cervarix, H1N1 pandemic Flu vaccine, quadrivalent seasonal Flu vaccine, Shingrix) as well as to the worldwide license maintenance of the entire GSK vaccines portfolio (N = 25+ products), leading to submissions of hundreds of CMC variations every year. Interactions with worldwide Regulatory Authorities (e.g. FDA, EMA, PMDA, Korea MFDS, etc).
- Worldwide regulatory guidance and requirements: Deep knowledge of US and EU requirements and hands on experience of other countries such as Canada, Japan, China, South Korea, etc.
- Non-clinical Regulatory Expertise: Authoring of 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.).
- Change management: supported 3 major organizational changes.
- Objective-driven mindset with a can do attitude. Strong sense of planning and prioritization, and the ability .to work with all levels of management, influence others, solve problems and take tough decisions
