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TRACY PARKER

@tracyparker

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Experienced Regulatory Operations Specialist with expertise in eCTD submissions.

United States

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What I'm looking for

I am seeking a role that values regulatory compliance and offers opportunities for professional growth.

I am an experienced Regulatory Operations Specialist with a strong background in eCTD submissions, quality control, and regulatory compliance within the pharmaceutical industry. My expertise spans across various regulatory guidelines, including FDA, ICH, and 21 CFR 11, allowing me to ensure that submissions are accurate and timely. I have a proven track record of collaborating with cross-functional teams and vendors, which has been crucial in maintaining high standards in regulatory submissions.

Throughout my career, I have been recognized for my strong analytical skills and attention to detail, particularly in reviewing documents and troubleshooting errors. My role as a Senior Clinical Trial Associate at Catalyst Clinical Research involved conducting audits and ongoing quality control reviews, where I acted as a subject matter expert for Medidata systems. I have also developed training materials and SOPs, showcasing my commitment to fostering a culture of compliance and excellence.

Experience

Work history, roles, and key accomplishments

Sr. Clinical Trial Associate

Catalyst Clinical Research

Jan 2020 - Dec 2023 (3 years 11 months)

Conducted quarterly audits and ongoing QC reviews of TMF documents to ensure compliance with internal SOPs and regulatory guidelines. Acted as SME for Medidata CTMS, eTMF, and Montrium; led team training and authored job aids.

Medidata CTMS Montrium TMF Regulatory Compliance Quality Control SOP Development Auditing

Corporate Administration Manager

Catalyst Clinical Research

Jan 2019 - Dec 2020 (1 year 11 months)

Provided high-level administrative support to executive leadership, managing travel coordination, internal communications, and CRM systems. Created SOPs, managed facility logistics, and maintained records and scheduling.

Administrative Support CRM SOP Development Internal Communications Records Management Scheduling

Regulatory Affairs Specialist / Operations Manager

Biostudy Solutions, LLC

Jan 2015 - Dec 2019 (4 years 11 months)

Supervised compilation and quality review of eCTD submissions in compliance with FDA requirements, acting as primary liaison between clients, vendors, and regulatory teams. Reviewed and corrected regulatory documents, ensuring error-free submissions, and trained junior staff in regulatory publishing tools and submission processes.

FDA Quality Regulatory Affairs Staff Training

Clinical Document Coordinator / Regulatory Specialist

Biostudy Solutions, LLC

Jan 2012 - Dec 2015 (3 years 11 months)

Led preparation and formatting of Module 5 submissions for ANDA and clinical reports. Developed and executed QC processes using Debenu and AutoBookmark, and created templates and SOPs for submission documentation and compliance.

Module 5 Submissions ANDA Quality Control Debenu AutoBookmark SOP Development Regulatory Compliance

Clinical Document Coordinator

AAIPharma (now Alcami)

Jan 2007 - Dec 2010 (3 years 11 months)

Supported eCTD document preparation and publishing for FDA submissions, maintaining project timelines, quality standards, and regulatory formatting. Utilized Adobe Acrobat and AutoBookmark to ensure submission accuracy.

Regulatory Submissions Adobe Acrobat AutoBookmark Project Timelines Quality

Education

Degrees, certifications, and relevant coursework

Katharine Gibbs College

Associate of Science, Business Administration and Management

Focused on developing core business skills, including administrative procedures, office management, and foundational business principles. Gained practical knowledge in organizational operations and support functions.