Senior Regulatory Affairs CMC Associate

Iovance Biotherapeutics

23h•$140,000 - $160,000•Remote

About The Position

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. Iovance seeks a highly motivated Senior Regulatory Affairs Specialist. The successful candidate has experience planning and managing regulatory authority submissions. He / She 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.

Requirements

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 8 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.
Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
Familiarity with ICH eCTD structure, knowledge of major market post approval change requirements, and ability to assess impact to CMC content clinical and commercial applications.
Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
High attention to detail and accuracy.
Excellent written skills and the ability to form defensible arguments based on data, literature references, industry standards, and country regulations/guidelines.
Excellent organizational and planning skills is a requirement.
High level of motivation and proactiveness required to engage in both in-person and remote team members.
Excellent interpersonal, verbal and written communication skills.
Ability to work both independently and collaboratively as part of a team.
Comfortable in a fast-paced small company environment with ability to adjust workload based upon changing priorities.

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.