• Supported Product Development Regulatory Affairs activities primarily for rare disease product development. International multi-functional teams focused on product registration in the U.S., E.U., and Canada marketso Led, coordinated, and authored Module 1 activities for a sNDA briefing package and filingo Coordinated and led the logistics for a Health Canada Redaction processo Prepared for and participated in a U.S. FDA product review meetingo Researched and provided strategic guidance on the use of a Priority Review Vouchero Worked with cross-functional stakeholders to support development of Briefing Packages for multiple programso Ensured compliance and timeliness in investigator submissions and eTMF reviewso Prepared and submitted FDA Information Request responses for multiple programso Facilitated Regulatory Affairs Functional Team meetings and maintained key documents for multiple programso Participated in global team discussions to develop key regulatory strategy• Other Activitieso Engaged the department in teambuilding activities as a member of the Fun Committeeo Supported outreach to disabled students committed to a career in science

• Interacted with buyers and vendors to resolve multiple issues in a timely manner simultaneously• Participated in the creation of new and more efficient protocols• Led the training of employees on new tasks• Proficient with Excel, SAP, and gSuite programs

The WESTT Program is a federally funded program that conducts research to determine whether algae makes a suitable biofuel or not.• Research on the ability of algae to serve as a biofuel• Ran Dissolved Reactive Phosphorus and multiple Solids test for algae• Prepared solutions and washed glassware with acids• Filtered samples (G4 and .45 filters)