--- title: 'Associate Director, Regulatory Affairs at Iovance Biotherapeutics' canonical: 'https://feeny.ai/job/associate-director-regulatory-affairs-iovance-biotherapeutics-remote-gykv39fnzpfw' type: 'job' last_seen: '2026-10-15' --- # Associate Director, Regulatory Affairs at Iovance Biotherapeutics - **Company:** Iovance Biotherapeutics - **Location:** Remote - **Compensation:** $185k–$210k - **Work type:** remote - **Posted:** 2026-09-30 - **Last confirmed live:** 2026-10-15 - **Apply:** https://job-boards.greenhouse.io/iovancebiotherapeutics/jobs/5438050008 ## Job description About Iovance Biotherapeutics, Inc. [Iovance Biotherapeutics](https://www.iovance.com/), Inc.  is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The [Iovance TIL platform](https://www.iovance.com/our-science/til-platform/) spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit [www.iovance.com](http://www.iovance.com/). Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on [www.iovance.com](http://www.iovance.com/). ## Overview The Associate Director, Regulatory Affairs, is responsible for leading one or more drug development programs, with specific emphasis on US and global (Ex-US) regulatory strategy, regulatory submissions, and interaction with global regulatory authorities including Health Canada, MHRA, EMA, Swiss Medic and TGA. The ideal candidate must have a good understanding and experience in clinical development strategies and health authority expectations for biologic products with novel cell and gene therapy for oncology indications preferred. The position reports to the Senior Vice President, Regulatory Affairs. Essential Functions and Responsibilities - Collaborates closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks. - Plans, manages, and creates Clinical Trial Applications, Market Applications, and amendments. - Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy. - Leads cross-functional teams in developing strategic briefing packages and in preparing for health authority meetings or interactions. - Ensures that evolving global regulations, guidelines, and health authority expectations, especially those related to biologics or ATMPs such as cell therapy products, are incorporated into program decision making. - Works within the department and with other functional areas on process improvements. - Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. - Perform miscellaneous duties as assigned. Required Education, Skills, and Knowledge - BS degree in life sciences required. - Minimum 5 years of experience in regulatory affairs with a doctorate degree (ie, MD, PhD, PharmD, or equivalent), 8 years with Master’s Degree, or 10 years with a Bachelor’s degree. - Late‑stage experience in oncology drug development. - Experienced in creating and negotiating the clinical-regulatory aspects of oncology drug development programs with health authorities, including Ex-US. - Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents, e.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries. - Able to write clearly and concisely, within agreed timelines. - Able to simultaneously manage multiple projects and submissions, with flexibility to pivot based on new data, program changes, and/or external influences. - High attention to detail and accuracy. - High organizational and planning skills. - Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships. - Excellent interpersonal, verbal, and written communication skills Preferred Education, Skills, and Knowledge - Advanced degree preferred (MS, MPH, PharmD, PhD). - Experienced in the creation, submission, and negotiation of market applications preferred. 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 manage work-related stress; ability to manage 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 $185,000—$210,000 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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