Regulatory Affairs CMC Associate

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

Iovance seeks a highly motivated Regulatory Affairs CMC Associate II. The successful candidate has experience planning and managing regulatory authority submissions. This role will coordinate CMC submissions across multiple products, supporting management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments. This role will be responsible for the preparation and adaptation of submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements and may be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries). 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. Another important aspect of this role is the capacity to contribute to the development and execution of optimal CMC life cycle management of clinical and commercial products, with an emphasis on change management.