Regulatory Publishing Manager

Net2Source Inc.; Princeton (NJ); Hybrid; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Regulatory Publishing Manager. This role involves overseeing the eCTD publishing process and document management, ensuring compliance with health authority guidelines. The ideal candidate will possess deep expertise in regulatory affairs and strong technical skills, with a commitment to quality and collaboration. This 6-month contract opportunity offers a hybrid work model, emphasizing flexibility and work-life balance.

Qualifications

• 5+ years in Regulatory Operations or related functions.
• 3+ years in regulatory publishing with drug development processes.
• Strong technical skills with compliance and publishing tools.

Responsibilities

• Publish eCTD submissions and documents in alignment with health authority guidelines.
• Ensure consistent formatting of authored documents according to standards.
• Collaborate with teams to resolve issues in published submissions.

Skills

eCTD guidance

Regulatory affairs

Document management systems

Electronic document management systems

Collaboration

Education

Bachelor's degree in business administration or life sciences

Tools

Veeva Vault RIM

Acrobat

DXC Toolbox

Job description

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Base pay range

$45.00/hr - $50.00/hr

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Job Title: Regulatory Publishing Manager

Location: Princeton, NJ, 08540

Hybrid: 3 days onsite (Tuesday to Thursday).

Duration: 06 months contract (possibility of extension or conversion)

Job Description

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.

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.

Required experience:

• At least 3 years in regulatory affairs, focusing on publishing.
• Familiarity with drug development processes (e.g., IND, NDA).
• Strong technical skills, specifically with electronic document management systems (EDMS) and publishing tools.
• Experience with ECTD (electronic common technical document) submissions is key.
• Nice-to-have: Experience with the Viva system, but other document management systems are acceptable.

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.

Primary Responsibilities:

• Using client'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 client'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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research

• Industries

  Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research

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