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Regulatory Publishing Manager I

San Diego, CA 92130

Posted: 06/24/2025 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12201 Pay Rate: $50.00 - $53.00 Remote Friendly: Onsite

Job Description

Our client develops and commercializes therapies for hallucinations and delusions associated with Parkinson’s disease.


Duties: 
  • The 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 the 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.

Job Requirements

Skills:
  • Thorough working knowledge of eCTD guidances (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 3 years in Regulatory Operations or a related, relevant function.

Meet Your Recruiter

Melissa Politron
Recruiter

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

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About San Diego, CA

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