Senior Regulatory Affairs CMC Associate

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

Gegründet 2014

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Iovance Biotherapeutics, Inc. ist ein Pionier in der innovativen Krebsbehandlung, indem es die Fähigkeit des menschlichen Immunsystems nutzt, um verschiedene Krebszellen in jedem Patienten zu erkennen und anzugreifen. Das Unternehmen konzentriert sich auf die T-Zell-basierte Immuntherapie, insbesondere die Tumor-infiltrierende Lymphozyten (TIL) Therapie, bei der die TILs eines Patienten zur Krebsbekämpfung gestärkt werden. Die TIL-Therapie von Iovance wird in klinischen Studien bei verschiedenen fortgeschrittenen soliden Tumorkrebsarten untersucht. Zudem treibt das Unternehmen gentechnisch veränderte TIL-Therapien voran und erforscht potenzielle Anwendungen der PBL (periphere Blutlymphozyten) Therapie für Blutkrebserkrankungen. Als führendes Unternehmen in der Zelltherapie besitzt Iovance ein hochmodernes Zelltherapiezentrum in Philadelphia, um seine Therapien unter Verwendung eigener GMP herzustellen. Das Unternehmen steht an der Spitze der Entwicklung von personalisierten und patientenspezifischen Krebsbehandlungen.

Beschreibung

• 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. • Perform miscellaneous duties as assigned.

🎯 Anforderungen

• 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.

🏖️ Vorteile

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