Melissa, PhD, is a distinguished C-Suite Executive specializing in Regulatory Affairs, Quality Assurance, and Clinical Affairs at Matrix Group. With a robust background as a serial entrepreneur and a seasoned regulatory affairs professional, she brings a wealth of expertise to the pharmaceutical, medical device, and...
Melissa, PhD, is a distinguished C-Suite Executive specializing in Regulatory Affairs, Quality Assurance, and Clinical Affairs at Matrix Group. With a robust background as a serial entrepreneur and a seasoned regulatory affairs professional, she brings a wealth of expertise to the pharmaceutical, medical device, and biotechnology sectors. Her extensive medical training and experience working with all primary divisions of the FDA—CDER, CDRH, and CBER—equip her with a comprehensive understanding of the regulatory landscape. Over the years, Melissa has successfully prepared and submitted numerous regulatory filings, ensuring compliance and facilitating the timely approval of innovative therapies.
In her current role at Matrix Group, Melissa serves as a senior strategist for product development, focusing on cutting-edge areas such as oncology, personalized medicine, and pharmacogenomics. She leads key projects that aim to advance clinical protocols and enhance patient outcomes, leveraging her deep knowledge of clinical informatics and Good Laboratory Practices (GLP). Her strategic vision is instrumental in navigating the complexities of regulatory pathways, particularly in the rapidly evolving fields of cancer treatment and cardiology.
Melissa's commitment to excellence and her ability to foster collaboration across multidisciplinary teams have made her a trusted advisor in the industry. Since transitioning to consulting in 2017, she has continued to empower organizations to innovate while maintaining rigorous quality standards and regulatory compliance. Her passion for advancing healthcare solutions and her expertise in regulatory affairs position her as a pivotal figure in shaping the future of life sciences.
