Role Description The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as: - Core/Site document collection and approval - ICF customization and approval - IRB/EC and CA/ MoH submissions - Delivery of quality IMP release packages Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities. Essential functions of the job include but are not limited to: - Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery. - Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution. - Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation. - Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up. - Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines. - Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels. - Responsible to co-ordinate translations for documents required for submissions. - Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables. - Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country. - If needed, directly support country or site level activities start up activities. - Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors. - Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries. - Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL. - Interact with clients in proposal activities, including slide development and client presentation as required. Qualifications - Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience. - 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. - 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities. Requirements - Demonstrated leadership experience in driving cross-functional activities. - Excellent communication and organizational skills are essential. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. - Fluency in English and for non-English speaking countries the local language of country where position based. - Experience using milestone tracking tools/systems. Benefits - We strive to ensure employees feel appreciated for the contributions they make every single day. - You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

• Assist with preparing and verifying data for internal and external audits, ensuring accuracy and completeness. • Monitor data integrity within client and staff databases, reporting any potential discrepancies. • Compile reports and documents according to established guidelines. • Support audits and investigations, including scheduling, documentation, and communication. • Assist with communicating and upholding policies, procedures, and expectations to staff. • Responsible for the maintenance and distribution of client records in accordance with HIPAA regulations. • Facilitate the timely and accurate processing of incoming requests and information for various projects, workflows and initiatives. • Resolve daily and routine nature issues as well as exercise appropriate judgment for escalation.

POSITION SUMMARY Position Title: Regulatory Affairs Associate II Contractor Reports to: Senior Manager, Regulatory Affairs Status: Contractor Location: South San Francisco, CA/Remote Summary: 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. Qualifications Include: - 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 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. About Assembly Bio 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

JOB SUMMARY This role leads Quality Systems and Compliance, with responsibility for designing and implementing a Quality Management System (QMS) that supports current clinical development programs and the organization’s growing pipeline. The role partners closely with Regulatory, Medical, Clinical, R&D, and Technology leadership to ensure quality systems enable innovation, maintain compliance, and support continuous inspection readiness across U.S. and global clinical programs. This job is based in San Diego, CA, or can be remote, and based in the US KEY RESPONSIBILITIES - Lead the design, implementation, and ongoing effectiveness of the Quality Management System (QMS) - Establish policies, procedures, and governance frameworks covering core quality processes, including document control, change management, deviations, CAPA, training, and risk management - Act as a strategic quality partner to Regulatory, Medical, Clinical Operations, R&D, and CMC teams - Define and execute a quality roadmap that translates regulatory and quality requirements into practical, scalable operating models aligned with current compliance needs and future organizational growth - Partner with Regulatory and Clinical teams to ensure quality systems support global clinical trial programs, including alignment across regions. - Proactively identify and mitigate compliance risk through data-driven monitoring and governance - Define key quality metrics and dashboards to monitor system health, compliance trends, and continuous improvement opportunities - Foster a culture of accountability, transparency, and quality ownership across the organization - Provide quality oversight and coordination for health authority interactions, internal audits, and third-party audits, as applicable - Ensure inspection readiness for U.S. and global clinical programs through established quality systems, governance, and cross-functional alignment QUALIFICATIONS Education & Experience: - Bachelor’s degree in chemistry, biology, engineering, or related health science Experience: - 10+ years of progressive experience in Quality Systems, Compliance, and/or Quality leadership within a regulated industry - Experience designing, implementing, or improving Quality Management Systems - Experience leading initiatives, projects, or teams in matrixed or growing organizations - Experience partnering with cross-functional teams, including Regulatory, Medical, Clinical Operations, R&D, and Technology - Strong understanding of risk-based quality systems and continuous improvement concepts - Ability to define and use quality metrics to monitor system performance and compliance trends - Clear, effective communicator with the ability to influence and align stakeholders - Comfortable operating in environments with evolving processes and priorities. - Experience with electronic quality management systems (eQMS); Veeva experience a plus - Familiarity with global regulatory expectations applicable to clinical development, including U.S. and international considerations. - Working knowledge of GCP and applicable GMP principles as they relate to clinical quality systems - Experience supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaboration - Demonstrated ability to translate regulatory and quality requirements into practical, scalable processes ABOUT IAMBIC THERAPEUTICS Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai. MISSION & CORE VALUES Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies. PAY AND BENEFITS We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.