Regulatory Affairs CMC Associate II

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.

Essential Functions and Responsibilities

Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments.

Prepare and adapt submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements.

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).

Independently manages submission trackers for coordination of submissions across multiple products.

Maintains logs of clinical and commercial submissions and correspondence with FDA or other regulatory agencies.

Facilitate communication with Vendors/ CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner.

Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).

Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.

Prepare and compile effective presentations for external and internal audiences as needed.

Create documents in accordance with eCTD specifications.

Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

BS degree required; advanced degree (PharmD, PhD, Master’s) preferred.

Strong scientific or research background, with a focus in pharmacy, chemistry, or biology, preferred (or relevant experience).

Minimum 5 years’ experience in regulatory affairs or a related function in drug/biologic development.

Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus.