Kelly Bechter
Steamboat Springs,CO
Summary
Highly motivated and tenacious professional with a strong track record of quality project outcomes and customer service. Assist with preparation, assembly, and quality checks of electronic and paper submissions for delivery to FDA and other regulatory authorities including: Advertising and Promotional material, INDs, NDAs, IND/NDA amendments, meeting requests, post-authorization changes (CMC, clinical), NDA/IND annual reports, and post-marketing submissions. Professional and trusted disposition has led to the creation and cultivation of highly effective teams, and unwavering client loyalty.
Overview
12
12
years of professional experience
Work History
Regulatory Publishing Project Manager
PPD
12.2021 - Current
- Manage critical, high-impact eCTD submissions including Original BLAs, INDs, an EUA, and other regulatory filings, ensuring compliance with FDA and global regulatory requirements
- Instrumental in achieving historic regulatory milestones for Moderna's COVID-19 vaccine by successfully managing and delivering the submission of the full, initial BLA
- Leverage deep expertise in Moderna regulatory information systems and processes to ensure all submissions are meticulously prepared, resulting in 100% validation acceptance by regulatory authorities
- Collaborate with cross-functional teams including CMC, clinical, non-clinical, and labeling, to gather required documentation and ensure submission readiness
Principal Regulatory Affairs Specialist
PPD
01.2021 - 12.2021
- Exhibited unwavering commitment by working deligently to ensure the timely and accurate publishing of all Moderna regulatory submissions, playing a vital role in the emergency filings during the COVID-19 crisis.
- Served as lead publisher for diverse client base, leveraging extensive experience to educate clients on best practices to ensure quality and compliance of regulatory submissions
- Enhanced overall team competency and efficiency through the development of best practices for Advertising and Promotional eCTD submissions at PPD
Senior Regulatory Affairs Associate
PAREXEL
01.2020 - 01.2021
- Streamlined the conversion of Advertising and Promotional submissions across various products from paper-based to eCTD, resulting in greater efficiency for a large, multinational client.
- Supported production and quality control of electronic submissions for diverse clients, ensuring document lifecycle maintenance
- Working knowledge of global regulatory submission formats, industry standards, guidelines, software validation concepts, and publishing best practices
- Proficient in Microsoft Windows desktop and server environments; Microsoft Office products; Adobe Acrobat and plug-ins; Documentum and/or other document management systems; PAREXEL LIQUENT InSight; Extedo eCTD Manager Software; eCTD validation and viewing tools; and SmartDesk product lines
- Adopted a client-focused approach to regulatory submissions, tailoring strategies and communications to meet specific client needs and ensuring high levels of satisfaction
Associate PROS
PAREXEL
10.2017 - 12.2019
- Managed project activities for global client's submissions of Advertising and Promotional content to FDA (OPDP).
- Responsible for the preparation and publishing of submission documents
- Perform quality control of published output for completeness and accuracy in formatting and navigation
- Perform quality control of content for clinical documents
- Perform document management tasks including file transfer, tracking, and archiving.
Manager of Regulatory Operations and Research
CBR International
Boulder, USA
10.2016 - 10.2017
- Planned, compiled, and published all stages of eCTD electronic submissions to FDA using Extedo eCTD Manager software
- Converted paper regulatory submissions to eCTD and efficiently managed complete lifecycle of clients' dossiers
- Supervised and trained intern and associate positions, leading to successful and productive team outcomes
- Assisted in managing client regulatory programs by providing support in drafting briefing documents, annual reports, and pediatric waivers.
- Acquired new clients by engaging in business development activities and attending industry conferences.
Senior Project Associate
CBR International
05.2015 - 10.2016
- Partnered with worldwide, executive clients to ensure regulatory compliance in order to drive progress of drug development programs
- Provided project management for compiling and assembling electronic and paper regulatory submissions to the FDA
- Performed change and deviation regulatory assessments for approved products
- Supervisor to Business Operations Staff.
Regulatory Associate
CBR International
04.2012 - 05.2015
- Project Associate to successful client program that received FDA approval for a New Drug Application (NDA)
- Received outstanding reviews in executing FDA meeting logistics and onsite meeting organization & preparation
- Prepared various SOPs, instruction and information sheets that are being used throughout the company
Education
B.A. - Ecology & Evolutionary Biology
University of Colorado at Boulder
05.2011
B.A. - Sociology
University of Colorado at Boulder
05.2011
Skills
- Submission preparation and publishing
- Regulatory Compliance
- Customer Relations
- SharePoint; AWS; Adobe Acrobat & plug-ins; SmartDesk; Microsoft Office products
- PAREXEL LIQUENT InSight; Extedo eCTD Manager Software
- Documentum and/or other document management systems included VEEVA RIM; SharePoint; AWS
Timeline
Regulatory Publishing Project Manager
PPD
12.2021 - Current
Principal Regulatory Affairs Specialist
PPD
01.2021 - 12.2021
Senior Regulatory Affairs Associate
PAREXEL
01.2020 - 01.2021
Associate PROS
PAREXEL
10.2017 - 12.2019
Manager of Regulatory Operations and Research
CBR International
10.2016 - 10.2017
Senior Project Associate
CBR International
05.2015 - 10.2016
Regulatory Associate
CBR International
04.2012 - 05.2015
B.A. - Ecology & Evolutionary Biology
University of Colorado at Boulder
B.A. - Sociology
University of Colorado at Boulder