Responsible for management of the VVS Regulatory Affairs team, supporting all North America VVS sites.

Reporting directly to the Head of Viral Vector Services Regulatory Affairs, I work with clients to develop regulatory strategy, as well as implement, and maintain regulatory submissions through effective intelligence gathering, planning, and management of regulatory operations resources.

Senior leader for Regulatory and Quality reporting direct to the CEO. responsibilities included management of Regulatory Affairs (RA) and Quality Assurance (QA) activities at Lacerta Therapeutics, Inc.

I began with Ology as a QA Compliance Specialist, and was quickly promoted to a Manager, and then Senior Manager. My time at Ology gave me broad experience in the world of quality assurance for a large biologics manufacturer. I performed Regulatory/CMC writing & review of CMC sections for INDs, EUAs, and NDAs, and gained site master file and drug master file experience.• Provided quality and regulatory oversight for projects and products, including pre-clinical, clinical, and commercial manufacture of small molecule, biologics/vaccines, and combination products.• Involved in facility qualification of a 183,000-square-foot, multi-purpose, multi-product, Biosafety Level-3 capable biologics and vaccines manufacturing facility. • Disposition and release of all CGMP product, review of all QC batch data, audit host (client & FDA-regulatory) and QA oversight of manufacturing environments and clean utilities.

Shortly after beginning in the regulatory affairs field, I landed in management at RGI, where I managed all aspects of the quality system, including Quality Operations and FDA Regulatory Submissions.

After completing my studies in Biological Sciences, I switched gears to pursue a career in regulatory affairs. In this role, I developed technical files and product dossiers for international product registrations.

During my time as a scientist, I planned and executed research studies, collected and analyzed data, and wrote manuscripts and grants. • As a result of this role, I became proficient in Mammalian cell-culture, including sterile technique and transfection of cultured cells, analysis of protein/DNA/RNA expression and metabolic studies in both cultured cells and small animals.

Before pursuing my academic studies, I spent four years in the military, working as part of an elite Special Operations Unit in the United States Army. I gained combat leadership experience while conducting missions in support of Operation Enduring Freedom in Afghanistan. I served as Team Leader, providing team training in preparation for worldwide combat operations and was also cross-trained as a combat medic. • Combat trauma management certificate within the Army• Emergency Medical Technician certification in civilian sector• Honorably discharged after returning home from combat operations in Afghanistan in 2003.