Regulatory Affairs CMC Associate II

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🕒 Junho 2

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Iovance Biotherapeutics, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2014

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Iovance Biotherapeutics, Inc. está revolucionando o tratamento do câncer ao aproveitar a capacidade do sistema imunológico humano de reconhecer e atacar células cancerígenas diversas em cada paciente. A empresa se concentra em imunoterapia baseada em células T, especificamente a terapia com Linfócitos T Infiltrantes de Tumor (TIL), que consiste em revigorar os TILs de um paciente para combater o câncer. A terapia TIL da Iovance está sendo investigada em ensaios clínicos para diversos tipos de câncer sólidos avançados. Além disso, a empresa está avançando em terapias TIL geneticamente modificadas e explorando aplicações potenciais da terapia PBL (linfócitos do sangue periférico) para cânceres hematológicos. Como líder em terapia celular, a Iovance possui um moderno Centro de Terapia Celular na Filadélfia para fabricar suas terapias utilizando GMP proprietária. A empresa está na vanguarda do desenvolvimento de tratamentos contra o câncer personalizados e específicos para cada paciente.

Descrição

• 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.

🎯 Requisitos

• 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. • 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.

🏖️ Benefícios

• Health insurance • Paid time off • Professional development • Remote work options • Flexible work hours