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Regulatory Publishing Manager
12830 El Camino Real Suite 400 San Diego, CA 92130 US
Job Description
*Depending on experience
Job Category: Clinical Operations
Job Title: Regulatory Publishing Manager I
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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