Maria Amaya, PhD

Genentech, A Member of the Roche Group
Lead External Advocacy North America (Quality Policy)
Maria Amaya is the Lead External Advocacy, North America in Quality Policy & Advocacy at Roche. In this position, Maria works within Roche/Genentech Global External Advocacy community to develop and deliver innovative quality and CGMP regulatory pathways, and collaborate with internal and external stakeholders including support in harmonization and streamlining of regulations. Maria holds a PhD in Protein Chemistry and a Masters in Protein Engineering from the Paris-Sud University in France and a Bachelors in Chemistry from the National University in Colombia. She has more than 13 years of experience in the pharmaceutical industry working in Product Development, Manufacturing Technology, Regulatory and Quality & Compliance.

Related Articles

The Power of Fleet Management in Distributed Manufacturing
Technical
The Power of Fleet Management in Distributed Manufacturing
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to meet the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to adapt to the dynamic demands of modern healthcare. This article proposes a regulatory framework for distributed manufacturing using the concept of fleet management to address...
Potency Measurements for Cellular and Gene Therapy Products
Technical
Potency Measurements for Cellular and Gene Therapy Products

Cell and gene therapy (C&GT) products address various diseases at the cellular or genetic level, offer innovative treatment approaches, and represent a significant advancement in the field of medicine. However, developers of C&GT products face unique challenges due to their complexity, such as establishing assays that show a clear link between potency, mechanism of action (MoA), and...

PIC/S in Latin America: Harmonization of cGMP Procedures
Features
PIC/S in Latin America: Harmonization of cGMP Procedures

This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry. It also highlights Latin American regulators’ current perspectives on PIC/S membership to increase awareness and encourage open dialogue about harmonization, recognition agreements, and potential increase for export facilitation, all which...

Post-approval Change Management for Cell and Gene Therapy Products
Features
Post-Approval Change Management for Cell and Gene Therapy Products

Cell and gene therapy (C&GT) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...