Regulatory Affairs Associate Operations

Princeton, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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

Position Summary

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.

Primary Responsibilities

Using Acadias 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 Acadias 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.

Education/Experience/Skills

Bachelors 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.

Key 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
Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.
Must be able and willing to travel on occasion.

Physical Requirements

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.

Required Experience:

Please note that this position is based in Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Regulatory Operations Associate is responsible for publishing QC and transmittal of eCTD submissions as well as document formattin...