Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

The Regulatory Publishing Associate 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. This individual will have a clear understanding of electronic submission requirements including the eCTD structure, Word templates and styles.

Primary Responsibilities

• Using Acadia'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 and according to Acadia's Style Guide
• Perform document verifications and follow procedures to identify, document, and remediate findings
• Manage document management tasks including file transfer, storage, tracking, and archival services
• As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness
• Validate and 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
• Utilize Electronic Submission Gateway (ESG) to transmit submissions to FDA and other Health Authorities
• Update trackers, correspondence logs, metrics on daily/weekly/monthly basis as internal policies dictate
• Other activities as designated

Education/Experience/Skills

Requires a Bachelor's degree in Business Administration, Life Science discipline or related field. Targeting 3 years of experience in Regulatory Affairs Operations or relevant function. An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Working knowledge of eCTD guidances (e.g., ICH, FDA, EMA, etc.), requirements, and technologies
• Knowledge, understanding, and experience with Veeva VAULT RIM authoring workflows, document metadata, and naming conventions
• Strong working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Word, Acrobat, DXC Toolbox, authoring templates)
• 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
• Ability to deliver while working under pressure to meet tight deadlines

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs

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