--- title: 'Regulatory Affairs Associate (Contract) at 4D Molecular Therapeutics' canonical: 'https://feeny.ai/job/regulatory-affairs-associate-contract-4d-molecular-therapeutics-emeryville-w7ecmkgggfys' type: 'job' last_seen: '2026-11-01' --- # Regulatory Affairs Associate (Contract) at 4D Molecular Therapeutics - **Company:** 4D Molecular Therapeutics - **Location:** Emeryville, CA - **Work type:** hybrid - **Posted:** 2026-10-29 - **Last confirmed live:** 2026-11-01 - **Apply:** https://4dmoleculartherapeutics.com/careers/?gh_jid=4748983005 ## Job description Attention recruitment agencies: 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. 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 ## GENERAL SUMMARY 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. This role can be remote or hybrid. Strong preference is given to SF Bay Area/West Coast candidates. ## MAJOR DUTIES & RESPONSIBILITIES: - 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. - Ensure regulatory submissions' quality, completeness, accuracy, and compliance. - Support Health Authority interactions by preparing relevant documents and plans. - Attend cross-functional and departmental meetings. - Assist in the maintenance of regulatory dashboards, plans, timelines, and support tools. - Assist with regulatory intelligence and strategic planning. - Builds and maintains current knowledge of applicable regulatory requirements and performs assigned activities in accordance with company procedures and applicable regulations. - 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. ## QUALIFICATIONS: Education: - Minimum Bachelors degree in a relevant field. - Advanced certificate or degree a plus. Experience: - 1+ years of drug development experience in regulatory, clinical research/operations, clinical quality assurance, and/or medical writing. - Experience with gene therapy/biologics or ophthalmology therapeutic area a plus. Other Qualifications/Skills: - Basic to intermediate knowledge of 21 CFR, ICH, and GCP guidelines. - Basic to intermediate knowledge of CTD structure, format, and submission requirements. - Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches. - Flexibility and ability to prioritize and manage multiple tasks and projects simultaneously. - Proficiency with Microsoft Word, Outlook, SharePoint, and Adobe Acrobat. - Excellent oral and written communication skills. - Strong attention to detail and organizational skills. Travel: <5% Physical Requirements and Working Conditions: - 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. - Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). Base salary compensation range: $36.00-$39.00/hour 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. 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. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities ## About 4D Molecular Therapeutics ## Company Overview - **One-liner**: 4D Molecular Therapeutics is a late-stage clinical biotechnology company inventing and developing customized genetic medicines using a proprietary vector evolution platform to treat large-market diseases. - **Entity Type**: Public (NASDAQ: FDMT) - **Headquarters**: Emeryville, California, United States - **Founded**: 2013 - **Founders**: David Kirn, MD (Co-Founder, President, and CEO) ## Core Business - **Primary industry**: Biotechnology / Genetic Medicine / Gene Therapy - **Target customers**: B2B (partnerships with other biopharma companies) and B2C (patients with retinal and pulmonary diseases) - **Mission or purpose statement**: "To unlock the full potential of genetic medicines for large market diseases" by harnessing directed evolution to invent customized and enhanced vectors for transformative products. ## Products & Services - **4D-150**: A clinical-stage genetic medicine candidate for retinal vascular diseases (wet age-related macular degeneration and diabetic macular edema). It is designed as a single, routine, low-dose intravitreal injection that provides multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C). Currently in Phase 3 clinical trials (4FRONT-1 and 4FRONT-2) for wet AMD and Phase 1/2 for DME. - **4D-710**: An investigational genetic medicine candidate for cystic fibrosis lung disease. It uses the A101 vector for aerosol delivery of a corrective CFTR transgene (CFTR∆R) and is designed for patients ineligible for or who have discontinued CFTR modulator therapy. Currently in Phase 1/2. - **4D-175**: A preclinical candidate for geographic atrophy (a form of dry AMD) using the R100 vector to deliver a shortened form of human complement factor H (sCFH) to restore normal complement regulation. - **4D-725**: A preclinical candidate for alpha-1 antitrypsin (A1AT) lung disease using the A101 vector for aerosol delivery. ## Market Standing - **Valuation/Market Cap**: $756.4 million (as of latest data from LinkedIn) - **Key Metric**: Annual Revenue of $85.2 million (as of latest data from LinkedIn) - **Notable Investors/Partners**: The company is publicly traded (IPO in 2020). Key partnerships are sought for pipeline candidates like 4D-175 and 4D-725. - **Growth Signals**: The company is a late-stage biotech with two Phase 3 trials (4FRONT-1 and 4FRONT-2) for its lead candidate 4D-150 in wet AMD, and a Phase 1/2 trial for 4D-710 in cystic fibrosis. The company has a presence in Ecuador, France, and India. LinkedIn followers grew 24.7% year-over-year. ## Competitive Advantages - **Proprietary Vector Platform (Therapeutic Vector Evolution)**: The company uses directed evolution to create customized and proprietary AAV vectors (e.g., R100 for retina, A101 for lung) that are optimized for specific tissues and routes of administration, which is a significant differentiator from standard gene therapy approaches. - **Large-Market Focus**: Unlike many gene therapy companies targeting ultra-rare diseases, 4DMT is focused on large-market indications (wet AMD, DME, cystic fibrosis) with high unmet need, offering a potentially massive commercial opportunity. - **Durable, Single-Dose Therapies**: Their products are designed to provide multi-year efficacy from a single injection, which could dramatically reduce treatment burden for patients compared to current standard-of-care (e.g., frequent eye injections for wet AMD). ## Strategic Focus - **Advancing Late-Stage Pipeline**: The primary focus is executing the Phase 3 programs for 4D-150 in wet AMD and progressing 4D-710 in cystic fibrosis. - **Expanding Indications**: The company is exploring 4D-150 for diabetic macular edema (DME) and seeking partnerships to advance 4D-175 (geographic atrophy) and 4D-725 (A1AT deficiency). - **Platform Expansion**: Continuing to leverage the Therapeutic Vector Evolution platform to develop new genetic medicines for other large-market diseases. ## Why Work Here - **Mission-Driven Culture**: The company is deeply committed to "daring to cure" and unlocking the potential of genetic medicine for patients with devastating diseases. Core values include "Dare to Cure," "Break Boundaries," "Prepare & Execute Relentlessly," and "Beyond Yourself." - **Innovative Science**: Employees work on cutting-edge science at the intersection of gene therapy, vector engineering, and clinical development, tackling some of the biggest challenges in medicine. - **Collaborative Environment**: The company emphasizes teamwork, internal and external collaboration, and a culture that empowers innovation. - **Location & Perks**: Based in Emeryville, CA (San Francisco Bay Area). The company offers a competitive benefits package and a dynamic, collaborative environment. - **Diversity & Inclusion**: 4DMT champions diversity, equity, and inclusion through an employee-led initiative called "4Diversity," which partners with charitable organizations and focuses on social equity. - **Work Authorization**: Candidates must be authorized to work in the U.S. The company does not sponsor new nonimmigrant visa status petitions but welcomes candidates who require transfers or extensions. ## Sources 1. [4dmoleculartherapeutics.com](https://4dmoleculartherapeutics.com/) 2. [4dmoleculartherapeutics.com - About](https://4dmoleculartherapeutics.com/about/) 3. [4dmoleculartherapeutics.com - Careers](https://4dmoleculartherapeutics.com/careers/) 4. [4dmoleculartherapeutics.com - Pipeline](https://4dmoleculartherapeutics.com/pipeline/) 5. [LinkedIn - 4D Molecular Therapeutics](https://www.linkedin.com/company/4d-molecular-therapeutics-llc) ## Other roles at 4D Molecular Therapeutics - [Clinical Trial Manager (Contract)](https://feeny.ai/job/clinical-trial-manager-contract-4d-molecular-therapeutics-emeryville-ay2pgk896wdx) — Emeryville, CA - [Senior Payroll Manager (Contract)](https://feeny.ai/job/senior-payroll-manager-contract-4d-molecular-therapeutics-emeryville-2562qbx9b0md) — Emeryville, CA - [Director, IT Business Partner, R&D](https://feeny.ai/job/director-it-business-partner-r-d-4d-molecular-therapeutics-emeryville-e54sw1t7qbqz) — Emeryville, CA - [Senior Accountant](https://feeny.ai/job/senior-accountant-4d-molecular-therapeutics-emeryville-vh8ys1p9tr78) — Emeryville, CA - [Executive Director, Statistical Programming](https://feeny.ai/job/executive-director-statistical-programming-4d-molecular-therapeutics-united-sbx771erzng7) — United States - [Senior Director, Clinical Quality Assurance (CQA)](https://feeny.ai/job/senior-director-clinical-quality-assurance-cqa-4d-molecular-therapeutics-united-xhe4n9jrfe00) — United States - [Director, Corporate Counsel](https://feeny.ai/job/director-corporate-counsel-4d-molecular-therapeutics-united-states-tqb6yhgnqdae) — United States - [Senior Director, IT Compliance & Governance (Contract)](https://feeny.ai/job/senior-director-it-compliance-governance-contract-4d-molecular-therapeutics-p4334wpdrvzd) — United States - [Senior Business Systems Architect](https://feeny.ai/job/senior-business-systems-architect-4d-molecular-therapeutics-united-states-0jycx224r9tk) — United States - [Vice President, Clinical Development](https://feeny.ai/job/vice-president-clinical-development-4d-molecular-therapeutics-united-states-8zdnvfs5n4ha) — United States