Open to opportunities

Katron Owens

@katronowens

Message

I build compliant regulatory submissions and publishing systems for pharmaceutical and medical device products.

United States

Message

What I'm looking for

I'm looking for a role where I can apply regulatory publishing, submission management, and RIM systems experience while contributing to process improvements, cross-functional projects, and compliant Health Authority deliverables.

I build and dispatch eCTD, NeeS, and paper regulatory submissions, drawing on approximately 20 years in pharmaceutical, biologic, and medical device regulatory operations.

At Immunovant, I coordinate submission schedules, maintain Health Authority communication archives in Veeva Vault RIM, and help implement RIMSMART and Veeva RIM with IT and business stakeholders.

At Sarepta Therapeutics, I co-led publishing for an original BLA submission, managed publishing vendors, supported Veeva Vault implementation, and trained cross-functional Veeva subject matter experts. I also supported clinical publishing at Daiichi Sankyo and global submission publishing at Cognizant.

My work has included FDA-compliant submission publishing, document quality control, SOP development, regulatory records, product registrations, and employee training. I enjoy being challenged and exploring new aspects of my work environment.

Experience

Work history, roles, and key accomplishments

Current

Regulatory Operations Publishing Consultant

Current

Immunovant, Inc

Jun 2024 - Present (2 years 3 months)

Build and dispatch submissions (eCTD, NeeS, Paper) and coordinate with Regulatory colleagues to plan and maintain the schedule for upcoming submissions. Support efforts to further develop the company’s submission document processes.

Veeva Vault RIM Suite RIMSMART eCTD NeeS Regulatory Submissions Process Improvement Stakeholder Management

Regulatory Science Consultant

Advantage Personnel Resources, Inc.

Mar 2024 - Jun 2024 (3 months)

Wrote Standard Operating Procedures (SOP) and Working Procedures, quality-checked regulatory documents before submittal, and assisted with the update of Global Submission Processes and Calendar.

SOP Development Quality Checking Regulatory Submissions Process Improvement

Regulatory Affairs Submissions Publishing Manager

Sarepta Therapeutics

Jul 2019 - Feb 2024 (4 years 7 months)

Co-led an Original BLA Submission, maintained and supported Regulatory systems including Veeva RIM and Promomats, and liaised with stakeholders to ensure compliance of deliverables for Health Authority Submittal.

Veeva RIMS Veeva Promomats Starting Point ISI Toolbox eCTD FDA Guidance Documents Vendor Management Training

Clinical Regulatory Publisher

Daiichi Sankyo

Jan 2018 - Jul 2019 (1 year 6 months)

Served as departmental Subject Matter Expert for Veeva RIM, trained new employees, provided clinical document support to Medical Writing, and performed publishing QC on clinical reports.

Veeva RIMS Clinical Publishing and Medical Journals Document Formatting Word PDF Starting Point SOPs Training

Senior Data Analyst, Regulatory Publishing

Cognizant Technology Solutions

Aug 2016 - Jan 2018 (1 year 5 months)

Accounted for global Regulatory submission and dossier publishing day-to-day activities and deliverables, built and dispatched submissions, and interacted with scientific personnel for preparation and quality checking of reports.

eCTD NeeS Regulatory Submissions Quality Checking Training SOPs Working Instructions

Regulatory Affairs Specialist

ConvaTec Inc.

Sep 2014 - Aug 2016 (1 year 11 months)

Collaborated with international Regulatory Affairs teams to determine global requirements, maintained the US FDA FURLS database, and reviewed labeling and promotional materials for compliance.

FDA Regulations FURLS 510(K)Product Listing Change Control Label Review Post Marketing Activities

Regulatory Affairs Specialist

BSN Medical

Sep 2013 - Sep 2014 (1 year)

Verified and maintained global product registration materials, ensured submission timelines were met, and created and maintained product dossiers.

Regulatory Affairs Product Registrations Dossier Cross Functional Collaboration

Regulatory Operations Associate III

Merck Sharp & Dohme Corporation

Jun 2007 - Jun 2013 (6 years)

Compiled, formatted, and published regulatory submissions according to FDA guidelines, supported Regulatory Affairs personnel, and managed schedules for periodic safety reports.

ISI Publisher ISI Writer ISI Toolbox eCTD FDA Guidance Documents Document Management Training Scheduling

Documentation Specialist

Wyeth Pharmaceuticals

May 2006 - Jun 2007 (1 year 1 month)

Developed and administered a database for change control information, provided reports to global project teams, and verified quality of information in a global registration database.

Database Management Change Control Global Registration Reporting