Regulatory Affairs Manager- Publishing

Integrated Resources, Inc ( IRI ); Princeton (NJ); On-site; USD 100,000 - 120,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Delivery Lead in Recruitment to oversee eCTD submissions and regulatory publishing. The position, requiring a bachelor's degree and substantial experience in Regulatory Operations, emphasizes collaboration with IT and QA teams to meet industry standards and guidelines.

Qualifications

• Minimum of 5 years in Regulatory Operations or similar field.
• Experience in vendor selection and system implementation.
• Proficiency in document formatting and validation principles.

Responsibilities

• Publish and QC eCTD submissions and reports.
• Ensure documents meet regulatory standards and company style guide.
• Assist authors with document readiness and use of Veeva Vault RIM.

Skills

Regulatory guidance knowledge

Collaborative work with IT and QA

Document formatting expertise

Effective communication

Education

Bachelor’s degree in business administration or life sciences

Tools

eCTD publishing systems (IQVIA RIM Smart)

Document management systems (Veeva Vault RIM)

Acrobat

Job description

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Direct message the job poster from Integrated Resources, Inc ( IRI )

Delivery Lead - Recruitment at Integrated Resources, Inc ( IRI )

Pay $48/hr

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 company'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 company'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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Other

• Industries

  Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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