Caitlin Bancroft, JD, RAC

Senior Regulatory Affairs Specialist at Pharmatech Associates
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Contact Information
us****@****om
(386) 825-5501
Location
Fort Collins, Colorado, United States, US
Skills

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Credentials

  • Regulatory Affairs Certification (RAC)
    Regulatory Affairs Professionals Society (RAPS)
    Dec, 2019
    - Nov, 2024

Experience

  • Pharmatech Associates, a USP company
    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Senior Regulatory Affairs Specialist
      • Jun 2020 - Present

      • Assists in the preparation of regulatory documents for submissions to the FDA including writing, and placement in the eCTD hierarchy for pharmaceutical products and for electronic submissions for medical devices.• Coordinates and manages client deliverables supporting regulatory compliance.• Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. • Assists in business development by publishing articles, actively involved in professional and industry organizations.

    • Associate Regulatory Affairs Consultant
      • 2017 - Jun 2020

      • Reviewed FDA and EU regulations concerning quality management systems, current Good Manufacturing Practices, clinical evidence/trials, complaint handling, risk management, and registration requirements for product classification and regulatory compliance of medical device, pharmaceutical, biotech, and human tissue/cell products. • Facilitating medical device development in compliance with ISO 13485, 21 CFR 820 and ISO 14971 using design controls, including development of user needs, product requirements, verification and validation strategy, hazards analysis, risk assessment, and risk mitigation strategies.• Developing regulatory filings for drugs, biologics, and medical devices for the US and EU, including Q-Submission Requests, Premarket Notifications (510(k)), Clinical Evaluation Reports, Technical Files, INDs, NDAs, and BLAs.• Supporting GMP/QMS compliance audits by assisting with remediations and developing audit checklists for 21 CFR sections 820 (QMS), 210-211 (GMP), and 1271 (GTP), ISO 13485 (QMS), ISO 14155 (GCP), and ICH E6 (GCP). • Conducting legal and regulatory research on regulatory affairs, quality systems, and clinical affairs issues to support clients in the life sciences industry. • Facilitating the day-to-day operations of the clinical and regulatory affairs team. • Building relationships with current and potential clients to further business development.

  • Democratic Women of Loveland
    • Founding Board Member
      • Nov 2016 - 2017

      • Organized and co-founded this political advocacy group to provide an opportunity for continued political activism for volunteers following the November 2016 election; the group quickly grew to a current email list of 250 and meetings with 80+ attendees. • As a member of the Executive Committee and Board of Directors, filed articles of incorporation, wrote a mission statement and by-laws, established action groups, and appointed officers.• As the Technological Administrator, created digital and social media infrastructure, including an email account, message board for members, listserv, and Facebook group.• Build relationships with other community groups and local legislators to develop initiatives and activities, including organizing Loveland’s International Women’s Day Mixer to support local women-owned businesses.

  • Colorado Coordinated Campaign
    • Political Organizations
    • 1 - 100 Employee
    • Campaign Fellow
      • Aug 2016 - Nov 2016

      • Recruited and trained over 100 volunteers to canvass and register voters and contact supporters. • Organized and managed the campaign office, consistently meeting weekly volunteer and canvassing goals.

  • Health Insurance Counseling Project
    • Student Attorney
      • Jan 2015 - May 2015

      • Provided legal counseling for Medicare/Medicaid beneficiaries on healthcare access and coverage disputes.• Researched complex benefits, billing, and reimbursement issues to assist clients in obtaining provider services, prescriptions, and delivery of medical equipment.

  • National Abortion Federation
    • Legal Intern
      • May 2014 - Jul 2014

      • Tracked and analyzed litigation regarding state laws and regulations limiting the practices of healthcare providers.• Contributed to the research and development of a report on the treatment of patients at crisis pregnancy centers.• Advocated for policy reform after the Burwell v. Hobby Lobby case and relevant Capitol Hill developments.

  • Mic
    • United States
    • Online Audio and Video Media
    • 300 - 400 Employee
    • Columnist
      • Oct 2013 - Jan 2014

      • Published over 30 news articles and editorials covering domestic politics from a liberal perspective.

  • NARAL Pro-Choice Virginia
    • Legal Intern
      • May 2013 - Aug 2013

      • Initiated and conducted an undercover investigation into crisis pregnancy centers (CPCs) to identify instances of false medical information, illegal practices such as HIPAA violations, client manipulation, and anti-abortion biases. These findings were used by NARAL Pro-Choice America’s President Ilyse Hogue in an interview by Al Sharpton on PoliticsNation. • Wrote politician profiles and event summaries for NARAL Pro-Choice Virginia’s blog. • Researched and analyzed anti-abortion legislation and cases in Virginia.

  • NARAL Pro-Choice Missouri
    • Polical Intern
      • Jan 2012 - May 2012

      • Planned, coordinated, and marketed events such as documentary showings, rallies, fundraising events, and lobbying to promote education and advocacy.

  • St. Louis Interfaith Committee on Latin America
    • Community Organizing Intern
      • Aug 2011 - Dec 2011

       Planned and publicized events including speakers, dinners, and discussions Organized, recruited for and supervised a trip of 57 people to the School of the Americas Protest

  • Dean's Office, Parks College, Saint Louis University
    • Office Assistant
      • Dec 2010 - Aug 2011

       Provided customer service while routing calls for the nine departments Organized student records and facilitated events for faculty and students

  • Department of Public Safety, Saint Louis University
    • Community Service Officer
      • Sep 2008 - Oct 2010

       Maintained safe transportation services for community members Supported officers in securing events and premises at Chaifetz Arena Promoted to SLUride coordinator and helped train 15 employees and develop shift schedule

Education

  • The George Washington University Law School
    Doctor of Law (J.D.)
    2012 - 2015
  • Saint Louis University
    Bachelor of Arts (B.A.), Political Science and Government
    2008 - 2011
  • Universidad Alberto Hurtado
    2009 -
  • Universidad Latinoamericana de Ciencia y Tecnología
    2008 -
  • Universidad Internacional Meñendez Pelayo
    2007 -

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