Regulatory Affairs Associate Operations

Acadia Pharmaceuticals • Princeton, NJ

1d • Hybrid

About The Position

The Regulatory Operations 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.

Requirements

• Bachelor’s degree in a life science, information technology, business administration or a related field.
• Targeting 3 years of progressively responsible experience in regulatory operations or relevant function, preferably in a pharmaceutical or biotech environment.
• An equivalent combination of relevant education and experience may be considered.
• 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
• Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.
• Must be able and willing to travel on occasion.
• This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment.
• The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations.
• The employee must occasionally lift and/or move up to 20 pounds.
• This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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 according to Acadia’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
• Other responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level