--- title: 'VP, Regulatory Affairs Strategy at 4D Molecular Therapeutics' canonical: 'https://feeny.ai/job/vp-regulatory-affairs-strategy-4d-molecular-therapeutics-emeryville-4rnbpv9fy68w' type: 'job' last_seen: '2026-11-08' --- # VP, Regulatory Affairs Strategy at 4D Molecular Therapeutics - **Company:** 4D Molecular Therapeutics - **Location:** Emeryville, CA - **Work type:** remote - **Posted:** 2026-11-03 - **Last confirmed live:** 2026-11-08 - **Apply:** https://4dmoleculartherapeutics.com/careers/?gh_jid=4750027005 ## 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 biologics (aflibercept and anti-VEGF-C) with a single 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 and the second indication is diabetic macular edema, which are both in Phase 3 development. 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. We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our Core Values drive the way we work together: - Dare to Cure - Break Boundaries - Beyond Yourself - Prepare & Execute Relentlessly Join us in creating the future of genetic medicine. ## GENERAL SUMMARY 4D Molecular Therapeutics (4DMT), located in Emeryville, CA, is a clinical-stage biotechnology company developing targeted genetic medicines using its proprietary AAV vector platform to treat serious unmet medical conditions. The Vice President, Regulatory Affairs Strategy, reporting to the Chief Regulatory and Quality Officer, is the company’s senior global regulatory strategist, accountable for designing and executing integrated US, EU, and international regulatory strategies that take 4DMT’s programs from IND through BLA/MAA and approval in major markets. The role sets regulatory direction on program and executive teams, leads the company’s most consequential interactions with FDA, EMA, and other health authorities, and leads the Regulatory Strategy team. ## MAJOR DUTIES & RESPONSIBILITIES: - Develops and leads integrated global regulatory strategies (US, EU, UK, Japan, and other key markets) for 4DMT’s AAV gene therapy programs from IND through BLA/MAA and approval, aligned with corporate objectives and supported by risk assessments, probability-of-success analyses, and contingency plans. - Designs global development and submission sequencing, including CTA timing, BLA and MAA filing strategy, and use of FDA–EMA parallel scientific advice and other collaborative review mechanisms. - Builds regulatory evidence strategies for novel endpoints and trial designs, including surrogate or intermediate endpoints, external controls, and real-world evidence where appropriate, consistent with FDA and EMA expectations for gene therapy. - Serves as the regulatory lead on program and governance teams, translating regulatory requirements and precedent into development plans, target product profiles, and evidence-generation strategies. - Identifies and pursues expedited and special regulatory pathways in each region, including Fast Track, RMAT, Breakthrough Therapy, Priority Review, Accelerated Approval, the Commissioner’s National Priority Voucher program, PRIME, ILAP, SAKIGAKE, and orphan designations. - Plans and leads health authority interactions, including pre-IND, INTERACT, Type A/B/C, End-of-Phase 2, and pre-BLA meetings, EMA scientific advice, and PMDA consultations; directs briefing document strategy and preparation, prepares project teams, and serves as a primary company contact with FDA (CBER/OTP), EMA, and other agencies. - Leads regulatory strategy for, and oversees preparation of, major submissions, including INDs/CTAs and amendments, annual reports, DSURs, orphan and expedited program designation requests, pediatric plans (iPSP/PIP), and BLA/MAA, ensuring filings are accurate, high quality, and submitted on time. - Partners with clinical, nonclinical, CMC, biostatistics, safety/pharmacovigilance, and medical affairs to define submission content and to ensure development plans are acceptable to regulators. - In partnership with Regulatory CMC and Technical Operations, ensures regulatory strategy accounts for AAV-specific CMC topics, including potency assays, comparability, and manufacturing process changes. - Shapes target product profiles and target labeling strategy across regions in partnership with Medical Affairs and Commercial. - Provides regulatory strategy input to life cycle plans, including indication expansion, new populations, and post-approval commitments, in partnership with the Life Cycle Management team. - Partners with Regulatory Operations on submission planning and timelines for global filings. - Leads ex-US regulatory strategy and execution, adapting global plans to regional requirements (EMA/CAT, MHRA, PMDA, Health Canada, and others) and directing regional partners, CROs, and consultants. - Partners with Quality to support Pre-Approval Inspection and BIMO readiness, ensuring submitted content is consistent with actual processes and data. - Builds, leads, and develops the Regulatory Strategy team, including global regulatory leads, with responsibility for goal setting, budget, resourcing, and talent development. - Educates and trains company employees on regulatory requirements, processes, and health authority expectations. - Communicates regulatory strategies, risks, and probability of success to executive leadership, the Board as needed, cross-functional teams, and partners/collaborators; supports business development due diligence. - Maintains current knowledge of the global regulatory environment for gene therapy (including FDA CBER/OTP and EMA CAT/ATMP frameworks), regulatory precedent, and the competitive landscape, and communicates implications to program teams and senior management. - Shapes the external regulatory environment through engagement with industry groups, health authority workshops, and comments on draft guidance relevant to gene therapy. - Proactively identifies regulatory risks and proposes solutions that keep development plans on time while maintaining the highest standards of quality and compliance. ## QUALIFICATIONS: Education: - S. degree in the life sciences or a related discipline required - Advanced degree (Ph.D., J.D., PharmD, MBA, and/or M.S.) in the life sciences preferred Experience: - S. with 18+ years of experience in the biopharmaceutical or biotechnology industries, or 14+ years with an M.S. degree, or 10+ years with a PhD or PharmD, with the majority in Regulatory Affairs. - 8+ years of people management experience leading regulatory strategy teams. An equivalent mix of education and experience will be considered. - Experience within the viral vector gene therapy field required; AAV highly desirable. Direct experience with FDA CBER/OTP required. - Senior responsibility for at least one successful BLA or MAA (gene therapy, cell therapy, or biologic preferred), including direct ownership of global (US and EU) regulatory strategy through approval. - Demonstrated success negotiating novel development plans, endpoints, or expedited pathways with FDA CBER/OTP and EMA. - Track record leading EU regulatory strategy, including EMA scientific advice, PRIME or CAT interactions, and centralized MAA procedures; Japan or other international experience preferred. - Experience obtaining expedited program designations (e.g., RMAT, Breakthrough Therapy, Fast Track, PRIME, orphan). - Ophthalmology or pulmonology experience a plus. Qualifications/Skills: - Expert knowledge of global regulations and guidance (FDA, EMA, ICH, MHRA, PMDA) and how they shape an integrated global regulatory strategy. - Proven ability to develop and execute global regulatory strategies that deliver approvals. - Strong track record of collaborative working relationships with FDA, EMA, and other health authorities that have led to successful outcomes for the business. - Ability to work within a team environment, report on projects and drive them to conclusions. - Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines. - Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task to thrive in small company environment. - Ability to proactively identify challenges, possess strategic foresight and implement appropriate course of action - Must have thorough knowledge of drug development and regulatory submission processes. - Excellent scientific and regulatory writing skills, including briefing documents and responses to health authority questions. - Demonstrated experience preparing and filing FDA and EMA submissions, including a BLA or MAA, required. - Excellent organizational, communication and time management skills are required - Must be able to innovate, analyze and solve problems with minimal supervision and strong attention to detail. Travel: 15-25%, including international travel. Hybrid or on-site role, expected to be on site in Emeryville, CA at least three times a month. Physical Requirements and Working Conditions: - Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. - 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: $326,000 - $381,000 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. 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