Regulatory Affairs Associate II Contractor

Assembly Biosciences, Inc.•South San Francisco, CA

3d•$48 - $58•Remote

About The Position

The Regulatory Affairs Associate II Contractor supports regulatory activities across Assembly Biosciences’ development programs, including regulatory operations, document management, and meaningful contributions to regulatory strategy for assigned projects. This role is primarily responsible for tracking regulatory deliverables, maintaining document repositories and archives, and assisting with submission readiness and lifecycle management activities under direct supervision. The Associate will collaborate with cross-functional teams to ensure regulatory documents are complete, accurate, and readily available to support regulatory submissions and ongoing compliance. Specific responsibilities include, but are not limited to: Tracking regulatory deliverables, milestones, and timelines across development programs to ensure visibility and on-time completion. Maintaining regulatory document repositories (e.g., Veeva RIM, Veeva eTMF) including version control, accuracy checks, and archival of final documents. Performing detailed document quality checks (QC) to ensure formatting, completeness, and adherence to FDA eCTD specifications and internal SOPs. Supporting regulatory publishing activities, including document compilation, formatting, and hyperlinking/bookmarking under guidance. Coordinating with cross-functional teams (CMC, Clinical, Quality) to collect and organize required submission deliverables. Assisting in the preparation and maintenance of submission trackers, document lists, and regulatory correspondence logs. Supporting post-submission activities, including filing of regulatory correspondence and tracking of queries/responses. Contributing to the maintenance of Regulatory Operations processes, templates, and SOPs to enhance efficiency and compliance. Supporting inspection and audit readiness by ensuring regulatory records are organized and readily retrievable. Supporting transfer of regulatory documents to external partners as needed. Periodically conducting eTMF reviews for Regulatory and Safety documents This job description outlines the primary duties and responsibilities of the role; however, it is not intended to be all-inclusive. The scope of responsibilities may be modified, expanded, or adjusted at the discretion of the organization to meet evolving business needs.

Requirements

Bachelor’s degree in Life Sciences, Regulatory Affairs, or a closely related field combined with 2+ years of experience in regulatory affairs or equivalent.
Proficiency in Microsoft Office Suite (Word, Excel) and Adobe Acrobat for document handling.
Strong organizational skills with meticulous attention to detail and a high degree of accuracy.
Ability to manage multiple deliverables and meet tight deadlines in a fast-paced environment.
Clear and professional written and verbal communication skills

Nice To Haves

Experience with Smartsheets, Veeva RIM and eTMF preferred

Responsibilities

Tracking regulatory deliverables, milestones, and timelines across development programs to ensure visibility and on-time completion.
Maintaining regulatory document repositories (e.g., Veeva RIM, Veeva eTMF) including version control, accuracy checks, and archival of final documents.
Performing detailed document quality checks (QC) to ensure formatting, completeness, and adherence to FDA eCTD specifications and internal SOPs.
Supporting regulatory publishing activities, including document compilation, formatting, and hyperlinking/bookmarking under guidance.
Coordinating with cross-functional teams (CMC, Clinical, Quality) to collect and organize required submission deliverables.
Assisting in the preparation and maintenance of submission trackers, document lists, and regulatory correspondence logs.
Supporting post-submission activities, including filing of regulatory correspondence and tracking of queries/responses.
Contributing to the maintenance of Regulatory Operations processes, templates, and SOPs to enhance efficiency and compliance.
Supporting inspection and audit readiness by ensuring regulatory records are organized and readily retrievable.
Supporting transfer of regulatory documents to external partners as needed.
Periodically conducting eTMF reviews for Regulatory and Safety documents