Melanie Jacob Roberts
Philadelphia,PA
Summary
Regulatory operations and compliance leader with 10+ years of experience managing complex submissions, document publishing, and regulatory workflows in highly regulated environments. Proven expertise in preparing, formatting, and delivering submission-ready documentation aligned with federal requirements. Skilled in electronic document management systems, SOP development, and cross-functional collaboration to support timely, high-quality regulatory submissions. Adept at optimizing processes, ensuring audit readiness, and supporting full submission lifecycle activities.
Overview
23
23
years of professional experience
Work History
IP Compliance Manager, Penn Center for Innovation
University of Pennsylvania
Philadelphia, PA
01.2019 - Current
- Manage regulatory compliance and submission activities for a large intellectual property portfolio, ensuring alignment with federal reporting requirements (NIH, iEdison).
- Prepare, format, QC-reviewed, and publish complex regulatory documents for submission, ensuring accuracy and adherence to strict guidelines.
- Lead development and maintenance of SOPs and workflows to standardize submission processes and improve operational efficiency.
- Coordinate cross-functionally with legal, research, and external partners to ensure submission readiness and timely reporting.
- Perform internal audits and implement corrective actions to maintain compliance and inspection readiness.
- Manage electronic submission platforms (iEdison, ProposalCentral, Fluxx) to track, compile, and submit regulatory documentation.
- Advise leadership on regulatory requirements and changes, ensuring continuous compliance across programs.
- Partner with external IP firms to support full portfolio compliance audits and remediation efforts.
Senior Licensing Associate, Office of Research Services & Technology Transfer
University of Missouri – Kansas City
Kansas City, MO
01.2010 - 01.2019
- Managed a university intellectual property portfolio, ensuring full compliance with federal and state regulatory requirements.
- Prepared and formatted submission-ready documents including patents, agreements, and regulatory filings.
- Collaborated with legal and external stakeholders to ensure accuracy, completeness, and compliance of submissions.
- Developed templates, document standards, and workflows to streamline submission and publishing processes.
- Served on regulatory committees (IACUC, Biosafety), ensuring adherence to compliance standards and documentation accuracy.
United States Congressional Intern
Congressional Coalition on Adoption Institute
Washington, DC
01.2011 - 01.2011
- Drafted, formatted, and edited reports and presentations submitted to Congressional staff and stakeholders.
- Assisted with coordination of legislative submissions and special reports, ensuring accuracy and timeliness.
- Developed procedural manuals and guided VIP constituents, demonstrating strong organizational and document management skills.
- Office of United States Senator Roy Blunt
Communications Manager
The Maot Group/Targum Shlishi Foundation
Aventura, FL
01.2003 - 01.2010
- Oversaw office operations, coordinated large-scale projects, and managed complex filing/documentation systems.
- Edited, formatted, and maintained official documents, reports, and communications for senior leadership.
- Organized high-level meetings and events, demonstrating strong project coordination and attention to detail.
- Created and maintained highly effective EDM systems.
Education
Bachelor of Arts Degree - Psychology, Honors
University of Missouri-Kansas City
Kansas City, MOSkills
- Regulatory Submissions & Compliance
- Electronic Document Management: SharePoint, Box, In-house EDMS
- Document Formatting, Editing, and PDF Publishing
- Submission Platforms & Compliance Systems
- Microsoft Word (advanced formatting)
- SOP Development, Workflow Optimization & Process Improvement
- Submission Readiness & Timeline Management
- Cross-Functional Regulatory Collaboration
- Audit Management
- Project Management & Timeline Coordination
- Training & Leadership Support
Timeline
IP Compliance Manager, Penn Center for Innovation
University of Pennsylvania
01.2019 - Current
United States Congressional Intern
Congressional Coalition on Adoption Institute
01.2011 - 01.2011
Senior Licensing Associate, Office of Research Services & Technology Transfer
University of Missouri – Kansas City
01.2010 - 01.2019
Communications Manager
The Maot Group/Targum Shlishi Foundation
01.2003 - 01.2010
Bachelor of Arts Degree - Psychology, Honors
University of Missouri-Kansas City