Manager, Regulatory Affairs, CMC

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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

• Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments. • Prepares routine IND and CTA amendments. • Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule. • Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics. • Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program. • Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development. • Work within the CMC Regulatory Affairs team to gain consensus on proposed changes. • Negotiate with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations and guidelines, and industry standards. • Participate in risk mitigation by proactively identifying risk, developing options and contingency plans. • Assists in developing and managing Gantt charts (in conjunction with Program Management) and trackers for submissions across the multiple products. • Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

🎯 Requisitos

• BA/BS degree in related field required. • At least 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. • Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements. • Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships. • Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro. • High attention to detail and accuracy. • Excellent interpersonal, verbal and written communication skills. • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

🏖️ Benefícios

• Reasonable accommodations may be made upon request to enable individuals to perform essential functions.