Reports To: Director, Regulatory Affairs
Position Type: Salaried, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans.
Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
The Head of Regulatory Operations and Document Management serves as the business lead and program manager for the implementation, management and optimization of Tocagen’s electronic document management system (EDMS). They define the business process for electronic and paper filing, management, and storage systems. They provide technical support for the management of the Company’s EDMS, Veeva Vault, including clinical Trial Master File, quality records (e.g. SOPs, CMC documentation), regulatory submissions, and other Company documentation intended to support regulatory submissions, from set up through to final archival, ensuring compliance with company SOPs and process. With a focus on inspection readiness, monitors clinical Trial Master File (TMF) compliance and is responsible for preparation of documentation required for regulatory agency inspection and internal or external audits. Collaborates with multiple vendors in the set-up and consolidation of Company documentation. Performs periodic quality assessments of document management system where required. Mentors staff on document management process.
The Head of Regulatory Operations and Document Management also serves as the business lead and program manager for the implementation, management and optimization of Tocagen’s electronic Common Technical Document (eCTD) software. They define the business processes for managing, compiling and submitting timely regulatory submissions. They are also responsible for managing vendors and/or staff used to prepare, compile and submit regulatory submissions.
Duties and Responsibilities Include But Are Not Limited To:
- Responsible for leadership, direction and operational execution of regulatory submissions to ensure timely and quality creation and lifecycle management of global submissions:
- Drive and manage all aspects of planning and publishing submissions and/or submission components including all operational tasks associated with or in support of authoring, publishing, production (paper and electronic), and archiving (paper and electronic)
- Support transition from paper to electronic filing of regulatory submissions
- Work collaboratively with members of other departments to define specifications regarding submission-related deliverables
- Develop, implement and oversee maintenance of all technologies and infrastructure needed to support regulatory submissions
- Participate in the development and implementation of new regulatory policies, processes, systems, and SOPs
- Primary role as system owner to oversee initial implementation and integration of EDMS into current business practices:
- Select and implement document naming conventions;
- Define file structures;
- Serve as company expert (super-user role) on the document management system and stay current on changes and updates;
- Responsible for technical support in Company usage of EDMS, including routing process of documents for approval and signature as well as maintaining version control;
- Act as mentor for staff, providing training and support on document management activities to functional departments and external vendors;
- Ensure effective communication and issue escalation internally and with external vendors related to documentation;
- Prepare SOPs to keep current with industry changes on document management, quality, and archival
- Responsible for ensuring high quality regulatory document deliverables:
- Monitor completeness and quality of the Clinical TMF, including elements outsourced to CRO;
- Oversee consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process;
- Oversee consolidation of quality and regulatory records in the EDMS
- Responsible for supporting inspection readiness:
- Perform periodic quality assessment of Company records;
- With direction from designated inspection lead, aid in preparation of Company records for agency inspection
- Performs other duties as required.
Desired Knowledge and Abilities:
- Significant knowledge of systems and processes related to document management, as well as expertise in document management best practices.
- Hands-on regulatory submission experience and extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines.
- Experience managing various aspects of clinical trials and regulatory submissions.
- Current awareness of regulatory requirements for clinical trials and regulatory submissions (ICH/GCP, FCA, EU Directive, eClinical and eCTD systems, and publishing).
- Familiarity with Veeva Systems software.
- Superior planning and project management skills.
- Ability to multi-task in a fast paced environment.
- Ability to work independently and as part of a team.
- Takes active measures to solve problems and commit to a high level of service.
Education & Experience:
- Minimum 8+ years of experience in life sciences/biotechnology industry required, with 5-7+ years of experience in global Regulatory Affairs Operations with increased responsibility/leadership.
- Prior experience overseeing the compilation and submission of eCTD regulatory submissions.
- Prior experience training users on systems and processes related to good documentation practices and electronic publishing.
- Prior experience with BLA submissions preferred.
- Prior experience overseeing TMF creation and audits preferred.
- Bachelor’s degree or equivalent experience.
- Proficiency in Microsoft Office suite applications.
- Proficiency in Adobe Acrobat Professional, ISI Tools, and web-based document indexing and viewing applications.
- Knowledge of scanning, extracting, uploading, OCR, rendering, bookmarking/linking, document verification and compilation.