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Role Description

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.

• 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.

Qualifications

• 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.
• Experience with Smartsheets, Veeva RIM and eTMF preferred.

Requirements

• Pay Range: $48 - $58/hour
• The stated pay range 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 academic credentials and relevant experience will influence the actual salary offered.

Company Description

Assembly Bio (NASDAQ: 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 focused on the discovery of novel antivirals to treat devastating viral diseases, including HBV, hepatitis delta virus (HDV) and herpesviruses.

We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. 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 transform the lives of patients. We set our sights high—and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.

As an equal opportunity employer, we are committed to diversity and inclusion and will not tolerate discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

Information for Recruitment Agencies

Assembly Bio does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited. Please do not contact hiring managers or Assembly Bio employees directly with any information related to a resume or a candidate. We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search. Your willingness to comply with this will significantly impact any decision we may make about doing business with you.

Location

South San Francisco, California (Remote)

Department

250 Regulatory & Quality Assurance

Employment Type

Contractor

Compensation

$48 - $58/hr