Regulatory Publishing Manager I
Aequor JD ·www.aequor.com
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Job Title: Regulatory Publishing Manager IDuties
The Manager/Sr. 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 Acadia's 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 Acadia's 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:
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.
Frequently asked questions
Who is hiring for the Regulatory Publishing Manager I role?
Aequor JD is hiring for the Regulatory Publishing Manager I position, a Shazamme client. Apply directly on the employer's career site.
Where is the Regulatory Publishing Manager I job located?
The Regulatory Publishing Manager I role with Aequor JD is based in Piscataway, NJ, US.
What does the Regulatory Publishing Manager I role pay?
Aequor JD lists the Regulatory Publishing Manager I role at USD 50–56 per hour.
Is the Regulatory Publishing Manager I role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Regulatory Publishing Manager I role?
The Regulatory Publishing Manager I position is aimed at mid-level candidates.
How do I apply for the Regulatory Publishing Manager I role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.