James Mann
Harleysville,PA
Summary
Driven professional with experience developing, planning and managing all aspects of Regulatory Operations. Leader in the development, refinement, and implementation of internal systems, processes, procedures, work instructions and training programs for submission production and operational support activities. Actively seeks opportunities that offer personal growth, professional knowledge, increasing levels of work accountability and personal career development.
Overview
19
19
years of professional experience
Work History
Director, Regulatory Affairs, Submissions and Operations
Inovio Pharmaceuticals, Inc.
Plymouth Meeting, PA
03.2020 - Current
- Provide all functional program leaders and teams with support for compilation, publishing and archiving of all Regulatory documents
- Ensure submission deliverables are of high quality and meet or exceed technical document and industry standards.
- Implement, deploy, and manage submission publishing and information management systems, and ensure system users receive proper training and support.
- Ensure processes employed to develop, package, submit, and maintain regulatory compliance status of regulatory documents meet standards for health authority inspections.
Senior Director, Regulatory Operations & Information Systems Administration
TissueTech, Inc.
Miami, FL
07.2018 - 01.2020
- Supervises all aspects of the compilation of eCTD submission deliverables.
- Provide end-user support to authors of drug submission documents, clinical study reports, and clinical trial protocols for regulatory submission.
- Lead paper to electronic conversion initiatives for all active Regulatory applications and submission archive material(s)
- Acting participant in scoping and implementation of functional document management systems for Clinical, Marketing, Project Management and Regulatory Affairs (EDM and eCTD publishing systems).
Associate Director, Regulatory Affairs
Braeburn, Inc.
Plymouth Meeting, PA
06.2015 - 07.2018
- Identify, evaluate and implement Electronic Document Management System (EDMS) for Regulatory and Quality functions as well as system administration
- Evaluation and implementation of company's Electronic Publishing Suite.
- Participates in Agency/Sponsor communications (FDA Advisory Meetings, Type A/B Briefing Meetings and scheduled teleconferences) as application support as well as educational opportunities as related to Regulatory Strategy
- Contributing member of cross-functional teams, providing breadth of knowledge as it pertains to eCTD and Agency guidance.
- Supervises and finalizes all aspects of the compilation of eCTD submissions.
Manager, Regulatory Submissions Management, Global Regulatory Operations
Teva Pharmaceuticals
Frazer, PA
11.2010 - 06.2015
- Leading experience with document management technologies, electronic publishing processes, and applications for worldwide drug development and marketing applications.
- Accomplished in the preparation and timely submission of functional documents to health authorities, including NDAs, sNDAs, BLAs, INDs, MAAs, annual reports, clinical study reports, NDSs in CTD, and eCTD formats.
- Maintenance and management of submission schedule database.
- Allocation of operational staff to team projects to assure submission-ready compliance to both document and submission-level readiness.
- Scope, validate, implement, and support regulatory operations software, including EDMS and eCTD publishing systems.
- Performs quality reviews of submission documents based on company and health authority guidance and submission standards.
- Participates in both functional and cross-functional teams to provide expertise in process and standards, operational procedures, and evaluation of ongoing and future technologies.
- Exhibit and maintain a healthy leadership role, which includes training and guidance of colleagues in the evolving role of Regulatory Operations, including technologies, submission process, requirements, standards, and guidance interpretations.
Senior Regulatory Publishing Associate
Cephalon Inc.
Frazer, PA
08.2005 - 10.2010
- Provide first-line support to Regulatory Submission Leads in all aspects of submission planning, including coordination, logistics, and tracking, while applying electronic document and information management and publishing technology.
- Assist in piloting new technologies and practices to solve specific needs within the document management and publishing environment.
- Provided user requirements for new eCTD publishing platform and applications.
- Participated in user acceptance training and validation of global pharmaceutical document management system.
- Lead Publisher for first Cephalon eCTD IND using current document management and publishing technologies.
- Directly interact with technical support to identify and resolve system issues.
- Train and guide publishers (US & EU) with both routine and complex submissions.
- Authored training aids for specific types of submissions as a guide for both new hires and interns.
- Proficient in coordination, assembly, and publishing of electronic, e-hybrid, and paper submissions in eIND, CTD, and eCTD format.
Skills
- Regulatory System Implementation and Management
- Project / Submission Management
- Cross-functional Team Leadership
- Organizational Skills
- Effective Communication
- Adaptability and Flexibility
Education
- Temple University, Philadelphia, PA (1989-1991)*
- Villanova University, Villanova, PA (2008)
*Completed credit towards Bachelor's Degree in Biology
Timeline
Director, Regulatory Affairs, Submissions and Operations
Inovio Pharmaceuticals, Inc.
03.2020 - Current
Senior Director, Regulatory Operations & Information Systems Administration
TissueTech, Inc.
07.2018 - 01.2020
Associate Director, Regulatory Affairs
Braeburn, Inc.
06.2015 - 07.2018
Manager, Regulatory Submissions Management, Global Regulatory Operations
Teva Pharmaceuticals
11.2010 - 06.2015
Senior Regulatory Publishing Associate
Cephalon Inc.
08.2005 - 10.2010
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