Associate Director, Regulatory Affairs at Iovance Biotherapeutics

Job description

About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics , 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 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 . 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 . 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,