Colleen Borczak
Senior Manager, Regulatory Affairs & Quality Assurance
West Dundee,IL
Summary
Versatile Senior Manager specializing in Regulatory Affairs, as well as Quality Assurance, and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company.
Overview
12
12
years of professional experience
3
3
years of post-secondary education
Work History
Senior Manager
SAB Biotherapeutics, Inc
02.2023 - Current
- Key duties, in addition to those outlined in Manager role:
- Review data/ reports
- Draft quality systems manual
- Draft, review and approve all SOPs
- Assess vendor qualifications
- Assess change controls
- Continue to assist in compilation of regulatory eCTD submissions
Manager
12.2021 - 02.2023
- Compile and submit IND amendments and annual reports
- Collaborate with third-party submission groups
- Record meeting minutes during informal calls with FDA
- Participate in informal correspondence with FDA
- Coordinate meetings surrounding Regulatory Strategy
- Assist in drafting department SOPs
- Select Achievements:
- Initiate company use of FDA-approved IND and BLA submission templates
Senior Associate
Sagent Pharmaceuticals, Inc
09.2017 - 12.2021
- Collate product annual reports and supplements
- Review and compile promotional material submissions
- Manage five key contract manufacturing organizations
- Orchestrate and submit technology transfers to FDA
- Assess change controls for my assigned manufacturers
- Select Achievements:
- Instituted use of software now utilized company-wide
- Acted as scribe for FDA audit December 2019
- Appointed to oversee product tech transfers for identified contract manufacturing organizations
Associate, Regulatory
01.2016 - 09.2017
- Proof read, edit and organize electronic files to submit to FDA
- Process FDA correspondences
- Conduct annual SDS audit and manage SDS program
- Manage RA tracking database
- Select achievements:
- Selected to Change Control team
- Performed Docubridge validation for new system installation
- Cross-trained team members in promotional material submissions and SDS creation
- Submitted first electronic promotional piece
Lab Technician
Edward Hines Jr. VA Hospital
08.2014 - 12.2015
- Involved in infectious disease research concerning Clostridium difficile (C
- Diff)
- Independently grew cultures and performed restriction enzyme analysis to assess toxicity
Lab assistant
Illinois State University
10.2011 - 07.2014
- Key duties
- Collaborated in research experiments and data collection for Wren Crew and Entomology
Education
B.S - Biology, Spanish
Illinois State University
01.2011 - 05.2014
Skills
Regulatory Affairs
Quality Assurance
Documentation and reporting
Lean manufacturing and quality systems
Cross-functional communications
Federal Drug Administration
Product Information
Regulatory Agency Applications
Regulatory Policies
Application coordination
Standard operating procedures
Report and data review
Timeline
Senior Manager
SAB Biotherapeutics, Inc
02.2023 - Current
Manager
12.2021 - 02.2023
Senior Associate
Sagent Pharmaceuticals, Inc
09.2017 - 12.2021
Associate, Regulatory
01.2016 - 09.2017
Lab Technician
Edward Hines Jr. VA Hospital
08.2014 - 12.2015
Lab assistant
Illinois State University
10.2011 - 07.2014
B.S - Biology, Spanish
Illinois State University
01.2011 - 05.2014