Senior Manager of Regulatory Affairs

• Jan 2023 - Present

Regulatory Affairs Manager

• Feb 2022 - Dec 2022

Senior Regulatory Affairs Associate

• Jul 2021 - Feb 2022

Senior Regulatory Affairs Associate

• Apr 2020 - Jul 2021

Senior Regulatory Science Associate

• May 2019 - Apr 2020

Regulatory Affairs Intern in Program Management (Oncology)

• May 2018 - May 2019

• Supported U.S. regulatory lead by scheduling, submissions and generating/reviewing key deliverables including information requests, DSURs, protocol amendments, IBs, DILs for all teams • Interfaced with cross-functional groups to complete routine regulatory processes efficiently (TMF reviews, monthly IP submission, etc) according to all regulatory and compliance standards for 3 early stage and 1 late stage molecule • Represented U.S. regulatory at molecule study team meetings as primary… Show more • Supported U.S. regulatory lead by scheduling, submissions and generating/reviewing key deliverables including information requests, DSURs, protocol amendments, IBs, DILs for all teams • Interfaced with cross-functional groups to complete routine regulatory processes efficiently (TMF reviews, monthly IP submission, etc) according to all regulatory and compliance standards for 3 early stage and 1 late stage molecule • Represented U.S. regulatory at molecule study team meetings as primary point of contact between study teams and regulatory team • Supported U.S. partner to generate Module 1 deliverables for supplemental BLA filing for late stage molecule • Supported U.S. partner to generate deliverables for IND administrative split for early stage molecule • Efficiently conducted independent work while also collaborating with 4 different molecule teams on key deliverables • Facilitated collaboration between cross-functional teams to achieve team goals and demonstrated desire to pinch hit wherever necessary to support the team’s needs Show less • Supported U.S. regulatory lead by scheduling, submissions and generating/reviewing key deliverables including information requests, DSURs, protocol amendments, IBs, DILs for all teams • Interfaced with cross-functional groups to complete routine regulatory processes efficiently (TMF reviews, monthly IP submission, etc) according to all regulatory and compliance standards for 3 early stage and 1 late stage molecule • Represented U.S. regulatory at molecule study team meetings as primary… Show more • Supported U.S. regulatory lead by scheduling, submissions and generating/reviewing key deliverables including information requests, DSURs, protocol amendments, IBs, DILs for all teams • Interfaced with cross-functional groups to complete routine regulatory processes efficiently (TMF reviews, monthly IP submission, etc) according to all regulatory and compliance standards for 3 early stage and 1 late stage molecule • Represented U.S. regulatory at molecule study team meetings as primary point of contact between study teams and regulatory team • Supported U.S. partner to generate Module 1 deliverables for supplemental BLA filing for late stage molecule • Supported U.S. partner to generate deliverables for IND administrative split for early stage molecule • Efficiently conducted independent work while also collaborating with 4 different molecule teams on key deliverables • Facilitated collaboration between cross-functional teams to achieve team goals and demonstrated desire to pinch hit wherever necessary to support the team’s needs Show less

Graduate Student Researcher

• May 2013 - May 2018

• Planned, executed, and conducted rigorous scientific analysis of experiments addressing original research questions examining the relationship between arterial stiffness, macrophage biology, and CD44 in the context of atherosclerosis using both in vitro and in vivo models • Planned, executed, and conducted rigorous scientific analysis of experiments addressing original research questions examining the relationship between arterial stiffness, macrophage biology, and CD44 in the context of atherosclerosis using both in vitro and in vivo models

Project Team Member

• Feb 2017 - May 2017

- Coordinated with others to provide regulatory consultation to a nonprofit client by generating an actionable road map to expedite access of existing pharmaceuticals (approved for other indications) to treat patients with a rare disease that has no current standard of care - Collaborated with others to research solutions to generate innovative solutions to client’s problem, including off-label usage, FDA programs to expedite drug approval, and small clinical trial design - Conducted… Show more - Coordinated with others to provide regulatory consultation to a nonprofit client by generating an actionable road map to expedite access of existing pharmaceuticals (approved for other indications) to treat patients with a rare disease that has no current standard of care - Collaborated with others to research solutions to generate innovative solutions to client’s problem, including off-label usage, FDA programs to expedite drug approval, and small clinical trial design - Conducted primary research about FDA programs for rare diseases (i.e. orphan drug designation) and those designed to expedite drug approval - Synthesized information from FDA Guidelines to illuminate potential pitfalls associated with failed clinical trials and risks associated off-label usage - Demonstrated effective written and oral communication skills by presenting deliverable presentations to both team members and client Show less - Coordinated with others to provide regulatory consultation to a nonprofit client by generating an actionable road map to expedite access of existing pharmaceuticals (approved for other indications) to treat patients with a rare disease that has no current standard of care - Collaborated with others to research solutions to generate innovative solutions to client’s problem, including off-label usage, FDA programs to expedite drug approval, and small clinical trial design - Conducted… Show more - Coordinated with others to provide regulatory consultation to a nonprofit client by generating an actionable road map to expedite access of existing pharmaceuticals (approved for other indications) to treat patients with a rare disease that has no current standard of care - Collaborated with others to research solutions to generate innovative solutions to client’s problem, including off-label usage, FDA programs to expedite drug approval, and small clinical trial design - Conducted primary research about FDA programs for rare diseases (i.e. orphan drug designation) and those designed to expedite drug approval - Synthesized information from FDA Guidelines to illuminate potential pitfalls associated with failed clinical trials and risks associated off-label usage - Demonstrated effective written and oral communication skills by presenting deliverable presentations to both team members and client Show less

Undergraduate Research Assistant in Kaufer Laboratory

• Jan 2011 - Feb 2013

Designed and presented honors thesis poster Conducted research examining relationship between stress and female reproductive axis in rats Designed and presented honors thesis poster Conducted research examining relationship between stress and female reproductive axis in rats