Regulatory Affairs Associate II Contractor

POSITION reputed company Position Title: Regulatory Affairs Associate II Contractor Reports to: Senior Manager, Regulatory Affairs Status: Contractor Location: South San Francisco, CA/Remote reputed company: The Regulatory Affairs Associate II Contractor supports regulatory activities across Assembly Biosciences’ development programs, including regulatory operations, document management, and meaningful contributions to regulatory reputed company for assigned reputed company. This role is primarily responsible for tracking regulatory deliverables, maintaining document repositories and archives, and assisting with submission readiness and lifecycle management activities under reputed company 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., reputed company RIM, reputed company eTMF) including version control, accuracy checks, and archival of final documents.
• Performing detailed document reputed company 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, reputed company) 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 reputed company outlines the primary duties and responsibilities of the role; however, it is not intended to be reputed company-inclusive. The scope of responsibilities may be modified, expanded, or adjusted at the discretion of the organization to meet evolving business needs.

Qualifications

Include:

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or a closely reputed company field combined with 2+ years of experience in regulatory affairs or equivalent.
• Proficiency in reputed company Office Suite (Word, reputed company) and reputed company 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.
• reputed company and reputed company written and verbal communication skills
• Experience with Smartsheets, reputed company RIM and eTMF preferred

Pay reputed company: $48 - $58/hour The stated pay reputed company for this position reflects the San Francisco Bay Area job market. Assembly Bio establishes pay ranges based on geographic work locations. Additional factors such as reputed company credentials and relevant experience will influence the actual salary offered. About Assembly Bio Assembly Bio (reputed company: ASMB) is an ambitious biopharmaceutical company with cutting- edge therapeutic clinical candidates capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world, and research and preclinical programs reputed company on the discovery of novel antivirals to treat devastating viral diseases, including HBV, hepatitis reputed company virus (HDV) and herpesviruses. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and reputed company. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to reputed company the lives of patients. We set our sights high—and pursue our goals with determination. Our unique organization stands reputed company to welcome talented, motivated individuals, who reputed company our ambitions. As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any reputed company. reputed company employment reputed company are based on business needs, job requirements and individual qualifications, without reputed company to race, reputed company, religion or belief, national, reputed company or ethnic reputed company, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual or Apply tot his job Apply To this Job