--- title: 'Manager, Regulatory Affairs at Iovance Biotherapeutics' canonical: 'https://feeny.ai/job/manager-regulatory-affairs-iovance-biotherapeutics-remote-xqcxk2bpy6fs' type: 'job' last_seen: '2026-09-10' --- # Manager, Regulatory Affairs at Iovance Biotherapeutics - **Company:** Iovance Biotherapeutics - **Location:** Remote - **Compensation:** $140k–$160k - **Work type:** remote - **Posted:** 2026-06-25 - **Last confirmed live:** 2026-09-10 - **Apply:** https://job-boards.greenhouse.io/iovancebiotherapeutics/jobs/5262981008 ## Job description Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. ## Overview The Manager, Regulatory Affairs, represents Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives. An important aspect of this role is the planning and management of submissions. Attention to detail in written correspondence, in the maintenance of regulatory files, and ability to work with diverse internal and external stakeholders are also important factors for success in this role. Essential Functions and Responsibilities - Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments. - Prepares routine IND and CTA amendments. - Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule. - Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics. - Assists in developing and managing Gantt charts (in conjunction with Program Management) and trackers for submissions across the multiple products. - Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies. - Prepares templates or shells for specific submissions based on company standards. - Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. - Perform miscellaneous duties as assigned. Required Education, Skills, and Knowledge - BA/BS degree in related field required - 8+ years’ experience in regulatory affairs or a related function in drug/biologic development and a Bachelor’s degree, 6+ years with a Master’s degree, or 4+ years with a PhD. - Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format - Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements. - Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships. - Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro. - High attention to detail and accuracy. - Excellent interpersonal, verbal and written communication skills. - Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities Preferred Education, Skills, and Knowledge - Advanced degree preferred (or relevant experience). The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation. Physical Demands and Activities Required - Must be able to remain in a stationary position standing or sitting for prolonged periods of time. - Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. - Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. - This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. - Must be able to communicate with others to exchange information. Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines Work Environment This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. #LI-remote The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills. Pay Transparency $140,000—$160,000 USD The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time. Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com. By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our [Candidate Privacy Notice](https://www.iovance.com/privacy-policy/). ## About Iovance Biotherapeutics ## Company Overview - **One-liner**: Iovance Biotherapeutics is pioneering tumor infiltrating lymphocyte (TIL) cell therapies to develop personalized, one-time treatments for solid tumor cancers. - **Entity Type**: Public (NASDAQ: IOVA) - **Headquarters**: San Carlos, California, USA - **Founded**: 2007 (originally named Lion Biotechnologies, renamed Iovance Biotherapeutics in 2017) - **Founders**: Not publicly available (the company was formed through a merger and rebranding) ## Core Business - **Primary industry**: Biotechnology — Cell Therapy (Immuno-Oncology) - **Target customers**: B2B / B2G — Healthcare providers, clinical trial sites, and ultimately patients with advanced solid tumors (melanoma, non-small cell lung cancer, endometrial cancer, etc.) - **Mission or purpose statement**: To be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer, harnessing the immune system to recognize and attack diverse cancer cells. ## Products & Services - **Lifileucel (IOV-009)**: A one-time, personalized TIL therapy for advanced melanoma. It is the first approved TIL therapy for a solid tumor (FDA approved in early 2024 under the brand name Amtagvi). - **IOV-LUN-202**: An investigational TIL therapy for advanced non-small cell lung cancer (NSCLC) currently in Phase 2 clinical trials. - **IOV-END-201**: An investigational TIL therapy for advanced endometrial cancer currently in Phase 2 clinical trials. - **IOV-4001**: A next-generation, gene-edited TIL therapy (using TALEN technology to inactivate PD-1 expression) for solid tumors, currently in preclinical/early clinical development. - **IOV-3001**: An engineered IL-2 therapy (licensed from Novartis) designed to support TIL therapy efficacy, currently in preclinical development. - **Cell Therapy Manufacturing (iCTC)**: The company operates a 136,000-square-foot, state-of-the-art Cell Therapy Center in Philadelphia, PA, for proprietary GMP manufacturing of TIL therapies. ## Market Standing - **Valuation/Market Cap**: As of early 2026, market capitalization is approximately $2.5–3.0 billion (fluctuates with FDA news and clinical data). Check current price on NASDAQ: IOVA. - **Key Metric (Revenue)**: Iovance generated its first commercial revenue from Lifileucel/Amtagvi in 2024. Annual revenue for 2025 was approximately $180–220 million (estimate based on analyst reports; exact figure not yet fully disclosed). The company is not yet profitable. - **Key Metric (Funding)**: As a public company, Iovance has raised over $1.5 billion through public offerings and debt financings. Notable recent raise: a public offering in 2022 and subsequent at-the-market offerings. - **Notable Investors/Partners**: - Novartis (license partner for IOV-3001) - Major institutional investors (e.g., BlackRock, Vanguard, and several healthcare-focused funds) - Collaborations with major cancer centers for clinical trials (e.g., MD Anderson, Memorial Sloan Kettering, etc.) - **Growth Signals**: - FDA approval of Lifileucel (Amtagvi) in early 2024 — a landmark first-in-class approval for TIL therapy in solid tumors. - Rapid commercial launch and expansion of treatment centers across the U.S. - Multiple ongoing Phase 2/3 trials in large indications (NSCLC, endometrial cancer, frontline melanoma). - Investment in next-generation gene-edited TIL (IOV-4001) and engineered IL-2 (IOV-3001) to improve efficacy and expand addressable patient populations. ## Competitive Advantages - **First-to-market TIL therapy**: Iovance is the only company with an FDA-approved TIL therapy for a solid tumor (Amtagvi for melanoma), giving it a significant head start in manufacturing, commercial infrastructure, and physician education. - **Proprietary manufacturing platform**: The in-house iCTC facility in Philadelphia enables scalable, standardized GMP production of personalized TIL therapies, a major barrier to entry for competitors. - **Broad solid tumor pipeline**: Unlike CAR-T therapies (primarily effective in blood cancers), TIL therapy has shown promise across multiple solid tumor types, providing a large addressable market. - **Polyclonal T cell approach**: The therapy targets a broad range of neoantigens unique to each patient’s tumor, potentially reducing the risk of immune escape compared to single-target therapies. ## Strategic Focus - **Commercial expansion**: Scaling up the launch of Amtagvi for advanced melanoma and expanding treatment center network globally. - **Pipeline acceleration**: Advancing pivotal trials in NSCLC (IOV-LUN-202) and endometrial cancer (IOV-END-201) to secure additional FDA approvals. - **Next-generation innovation**: Developing gene-edited TIL (IOV-4001) to enhance persistence and efficacy, and engineered IL-2 (IOV-3001) to improve the TIL therapy cycle. - **Manufacturing optimization**: Continuing to improve manufacturing efficiency and turnaround time at the iCTC facility to support growing demand and reduce costs. ## Why Work Here - **Mission-driven culture**: The company is deeply patient-centric, with a clear focus on delivering transformative therapies to cancer patients. Employees often cite the meaningful impact of their work as a key motivator. - **Values**: Integrity, agility, innovation, collaboration, and excellence are core to the company’s operating philosophy. The culture emphasizes transparency, teamwork, and high ethical standards. - **Diversity, Equity, and Inclusion**: Iovance has a stated commitment to DEI, recognizing that internal diversity is critical to serving diverse patient populations and driving innovation. - **Remote/Hybrid policy**: Many roles (especially in clinical, medical affairs, marketing, and commercial functions) are remote or hybrid. Laboratory and manufacturing roles are based on-site in Philadelphia, PA (iCTC) or San Carlos, CA (HQ). - **Benefits**: Competitive salaries, annual cash bonuses, long-term incentives (stock options/RSUs), 401(k) with match, Employee Stock Purchase Plan, comprehensive medical/dental/vision (low employee cost), Health Savings Account contributions, paid parental leave, tuition assistance, wellness program (gym discounts), and professional development opportunities. - **Work environment**: Agile and fast-paced, typical of a biotech company at a critical growth stage. The company values data-driven decision-making and encourages employees to bring their best efforts every day. ## Sources 1. [iovance.com](https://www.iovance.com/) 2. [iovance.com - About Us](https://www.iovance.com/about-iovance-biotherapeutics/) 3. [iovance.com - Culture](https://www.iovance.com/culture/) 4. 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