Job Description

The Manager, Regulatory Publishing is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with health authority guidelines and industry best practices.

Primary Responsibilities:

• Using eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority guidelines and industry best practices.

• For authored documents, ensure formatting is applied consistently according to Style Guide.

• As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness.

• QC published eCTD submissions and reports, working collaboratively with teammates to resolve findings and issues.

• Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of Veeva Vault RIM.

• For clinical study reports, deliver Regulatory Operations kickoff slides (covering use of Veeva Vault RIM and tracking of appendices).

• For clinical study reports, work with SMEs/authors to track status of appendices and manage overall timelines for completion.

• As needed, work with system business owners, IT, and QA to support system. implementations and updates including execution of validation scripts.

Skills

Must have experience with/be proficiency in the following:

• Veeva Vault Experience
• Thorough working knowledge of eCTD guidance (e.g., ICH, FDA, EMA, etc.), requirements, and technologies.

• Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems.

• Demonstrated ability to work collaboratively with IT, QA, and vendors to develop, implement, and maintain regulatory systems.

• Working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Acrobat, DXC Toolbox, authoring templates).

• Understanding of computer system validation principles and change control processes.

• Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports.

• Demonstrated ability to effectively communicate in written and verbal media concepts related to regulatory systems and electronic submissions.

Education

• Bachelor’s degree in business administration, a life sciences discipline, information technology, etc.. A minimum of 5 years in Regulatory Operations or a related, relevant function

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