Experience

Kymanox

• United States
• Biotechnology
• 100 - 200 Employee

• Associate Director, Regulatory Affairs

  • Aug 2023 - Present



Enable Injections, Inc.

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Associate Director of Regulatory Affairs

  • Aug 2022 - Jul 2023

  Enable Injections is developing and manufacturing novel on-body delivery devicesfor subcutaneous administration of high-volume drug and biologic products• Served as FDA and Health Authorities submission lead and primary contact• Led and participated in health authority interactions (FDACDER/CBER/CDRH/OCP, EU Notified Body)• Served as the Regulatory lead on cross-company project teams to develop drug andbiologic combination products with key partners• Responsible for authoring regulatory submissions to FDA and Notified Bodies(IND, CTA, MAF, Technical Document, meeting requests and briefing books)Performed risk and regulatory impact assessments for change controls• Updated Enable Quality System procedures and templates to incorporate globalRegulatory requirements and industry standards Show less

• Senior Manager, Regulatory Affairs

  • Sep 2021 - Aug 2022

• Manager, Regulatory Affairs

  • Jan 2021 - Sep 2021

• Senior Regulatory Specialist

  • Jun 2019 - Jan 2021



Camargo, A Division of Premier Consulting

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Science Liaison

  • Sep 2018 - Jun 2019

  - Serve as a technical representative as part of Camargo's Commercial Solutions group - Assist with determining client Scope of Work to improve client experience and accuracy of proposals - Determine and analyze key measurable metrics to improve team efficiency

• Scientific and Regulatory Specialist

  • Aug 2018 - Sep 2018

  - Serve as Research Scientist and Team Lead for a wide variety of Regulatory and Drug Development programs, including INDs, NDAs, Pre-IND meetings, Feasibilities/Gap Analysis/Strategic Assessments, Orphan Designation Requests, Breakthrough Therapy and Fast Track Designation requests, with a particular focus on the 505(B)(2) regulatory pathway- Directly interacts with the FDA on behalf of clients as part of face-to-face meetings and WRO responses- Participates in Business Development actives to help define client Scope of Work and advise on Camargo's potential contributions to client objectives- Responsible for Project Management actives for all projects See less Show less

• Research Scientist

  • Jul 2016 - Jul 2018



National Institute of Environmental Health Sciences (NIEHS)

• United States
• Research Services
• 500 - 600 Employee

• IRTA Fellow

  • Jul 2014 - Jul 2016

  Researched the impact of environmental factors on mitochondrial DNA disorders in Dr. Bill Copeland's lab. Researched the impact of environmental factors on mitochondrial DNA disorders in Dr. Bill Copeland's lab.



Duke University

• United States
• Higher Education
• 700 & Above Employee

• Research Scholar

  • Apr 2014 - Jul 2014



North Carolina Biotechnology Center (NCBiotech)

• United States
• Biotechnology
• 1 - 100 Employee

• Research Analyst Intern

  • Mar 2014 - Mar 2014

  Created a Job Seeker Resource Database for use on the NCBiotech website. Created a Job Seeker Resource Database for use on the NCBiotech website.



Duke University Medical Center

• Hospitals and Health Care
• 700 & Above Employee

• Ph.D Candidate

  • Aug 2008 - Mar 2014

  Biochemical research on transcription elongation stalling and termination in Dr. Kenneth Kreuzer's lab Biochemical research on transcription elongation stalling and termination in Dr. Kenneth Kreuzer's lab



Indiana University School of Medicine

• Research Services
• 700 & Above Employee

• Research Assistant

  • Jun 2008 - Aug 2008



Rose-Hulman Ventures

• United States
• Industrial Machinery Manufacturing
• 1 - 100 Employee

• Intern

  • Sep 2007 - May 2008

  Chemical and Chemical Engineering based project for ConocoPhillips. Chemical and Chemical Engineering based project for ConocoPhillips.



Indiana University School of Medicine

• Research Services
• 700 & Above Employee

• Research Assistant

  • Jun 2007 - Aug 2007



Indiana University School of Medicine

• Research Services
• 700 & Above Employee

• Research Assistant

  • Jun 2006 - Aug 2006



Indiana University School of Medicine

• Research Services
• 700 & Above Employee

• Research Assistant

  • Jun 2005 - Aug 2005