Regulatory Publishing Manager

Integrated Resources, Inc ( IRI ); Princeton (NJ); Hybrid; Full time

Job summary

Integrated Resources, Inc ( IRI ) seeks a Regulatory Publishing Manager in Princeton, NJ, focusing on regulatory submissions for pharmaceutical products. With a hybrid work model, the role requires expertise in eCTD publishing and a strong understanding of regulatory guidelines. This position demands excellent communication skills and a collaborative approach to work with various stakeholders across regulatory operations. A Bachelor's degree and at least 5 years in a relevant field are essential for candidates aiming to contribute to effective publishing and compliance in an innovative environment.

Qualifications

• 5 years in Regulatory Operations or related function required.
• Experience with eCTD publishing and document management systems.
• Thorough knowledge of regulatory guidelines (ICH, FDA, EMA).

Responsibilities

• Publish eCTD submissions and reports in compliance with health authority guidelines.
• Ensure document formatting consistency and QC for published submissions.
• Coordinate with team members to resolve submission-related issues.

Skills

eCTD guidance

regulatory information management systems

document formatting

communication

Education

Bachelor’s degree in business administration or life sciences

Tools

Veeva Vault RIM

IQVIA RIM Smart

Acrobat

Job description

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Integrated Resources, Inc ( IRI ) provided pay range

This range is provided by Integrated Resources, Inc ( IRI ). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$45.00/hr - $47.00/hr

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Job Title: Regulatory Publishing Manager

Title : Princeton, NJ- Hybrid

Duration: 6 months +

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 Client 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 Client 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

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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