Regulatory Publishing Manager

Aequor; Princeton (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Regulatory Publishing Manager I for a 6-month contract with potential for extension. This role involves publishing regulatory submissions in compliance with eCTD guidelines and managing document integrity. The ideal candidate will possess strong knowledge of regulatory processes, eCTD systems, and collaborative skills to ensure the timely delivery of high-quality submissions.

Qualifications

• Experience with eCTD guidance (ICH, FDA, EMA).
• 5 years in Regulatory Operations or relevant role required.
• Proficient in regulatory publishing and document management.

Responsibilities

• Publish eCTD submissions and reports as per guidelines.
• Ensure consistent formatting of authored documents.
• QC eCTD submissions and collaborate to resolve issues.

Skills

Working knowledge of eCTD guidance

Experience in vendor selection

Collaboration with IT and QA

Document formatting knowledge

Understanding of system validation principles

Communication skills related to regulatory systems

Education

Bachelor's degree in business administration

Minimum of 5 years in Regulatory Operations

Tools

IQVIA RIM Smart

Veeva Vault RIM

Acrobat

DXC Toolbox

Job description

14 hours ago Be among the first 25 applicants

This range is provided by Aequor. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $60.00/hr

Direct message the job poster from Aequor

Job Title: Regulatory Publishing Manager I

Location: Princeton, NJ, and the other in San Diego, CA.

Duration: 06+ months with possibility of extension

Shift: Mon-Fri 40 hours/week

Duties:

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 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:

• 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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Science, and Manufacturing

• Industries

  Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Hospitals and Health Care

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