PAIGE/JOBBANK

Regulatory Affairs Associate (Contract)

Emeryville, CA, USCAPosted 31 Oct 2026Remotelocal_ats

<div class="content-intro"><p><strong><em>Attention recruitment agencies:</em></strong><em> All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.</em></p> <p> </p> <p>4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery</p></div><p><span style="text-decoration: underline;"><strong><span data-contrast="auto">GENERAL SUMMARY</span></strong></span></p> <p><span data-contrast="auto">The Regulatory Affairs Associate at 4D Molecular Therapeutics, Inc. (4DMT) will be supporting the Regulatory Project Team (RPT) to ensure the successful progress of 4DMT’s product pipeline toward regulatory approval and commercialization. The role will work within the RPT and with both internal and external stakeholders to ensure timely review and approval of various regulatory submissions. </span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></p> <p><span data-contrast="auto">This role can be remote or hybrid. Strong preference is given to SF Bay Area/West Coast candidates.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559738":0,"335559739":0}"> </span></p> <p><span style="text-decoration: underline;"><strong><span data-contrast="auto">MAJOR DUTIES & RESPONSIBILITIES:</span></strong></span></p> <ul> <li><span data-contrast="auto">Support US and global submission preparation by drafting and formatting relevant documents, coordinating cross-functional (e.g., CMC, nonclinical, and clinical) deliverables, and scheduling submissions.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Ensure regulatory submissions' quality, completeness, accuracy, and compliance.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Support Health Authority interactions by preparing relevant documents and plans.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Attend cross-functional and departmental meetings.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Assist in the maintenance of regulatory dashboards, plans, timelines, and support tools.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Assist with regulatory intelligence and strategic planning.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Builds and maintains current knowledge of applicable regulatory requirements and performs assigned activities in accordance with company procedures and applicable regulations.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li data-leveltext="·" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <p><span style="text-decoration: underline;"><strong><span data-contrast="auto">QUALIFICATIONS: </span></strong></span></p> <p><span data-contrast="auto">Education: </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li><span data-contrast="auto">Minimum Bachelors degree in a relevant field.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Advanced certificate or degree a plus.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <p><span data-contrast="auto">Experience: </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li><span data-contrast="auto">1+ years of drug development experience in regulatory, clinical research/operations, clinical quality assurance, and/or medical writing. </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Experience with gene therapy/biologics or ophthalmology therapeutic area a plus.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <p><span data-contrast="auto">Other Qualifications/Skills: </span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li><span data-contrast="auto">Basic to intermediate knowledge of 21 CFR, ICH, and GCP guidelines.</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></li> <li><span data-contrast="auto">Basic to intermediate knowledge of CTD structure, format, and submission requirements.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Flexibility and ability to prioritize and manage multiple tasks and projects simultaneously.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Proficiency with Microsoft Word, Outlook, SharePoint, and Adobe Acrobat.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Excellent oral and written communication skills.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> <li><span data-contrast="auto">Strong attention to detail and organizational skills.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <p><span data-contrast="auto">Travel: <5%</span><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="none">Physical Requirements and Working Conditions:</span><span data-ccp-props="{"201341983":0,"335559738":240,"335559739":240,"335559740":240}"> </span></p> <ul> <li><span data-contrast="none">Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.</span><span data-ccp-props="{"335557856":16777215,"335559739":0}"> </span></li> <li><span data-contrast="none">Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).</span><span data-ccp-props="{"335557856":16777215,"335559739":0}"> </span></li> </ul> <p><span data-contrast="auto">Base salary compensation range: $36.00-$39.00/hour</span></p> <p><span data-contrast="auto">Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. </span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p><div class="content-conclusion"><div>4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.</div> <div> </div> <div>Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities</div></div>

Source: local_ats. Description and metadata as published by the employer or its applicant tracking system on 2026-10-31. The apply link goes to the original source. Paige JobBank does not accept applications on the employer's behalf.