Director, Regulatory CMC

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

📋 Description

• Works closely with functional leaders to create the optimal development path for Iovance product candidates, negotiate optimal development paths within internal cross-functional teams and with health authorities, execute clinical-regulatory development plans on-time and while managing all identified risks. • Plans, manages, and creates Clinical Trial Applications, Market Applications and amendments. • Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy. • Leads cross-functional teams in preparing for health authority meetings. • Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making. • Works within the department and with other functional areas on process improvements. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

🎯 Requirements

• BS degree in life sciences. • Minimum 10 years’ experience in regulatory affairs • Late-stage experience in oncology drug development. • Experienced in creating and negotiating the clinical-regulatory aspects of oncology programs. • Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents. E.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries. • Able to write clearly and concisely, within agreed timelines. • Able to simultaneously manage multiple projects and submissions, with flexibility to pivot based on new data, program changes, and/or external influences. • High attention to detail and accuracy. • High organizational and planning skills. • Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships. • Excellent interpersonal, verbal and written communication skills

🏖️ Benefits

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