Associate Director – Regulatory Affairs

Job not on LinkedIn

🔥 56 minutes ago

🇺🇸 United States – Remote

💵 $185k - $210k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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

• Lead one or more drug development programs, focusing on US and global (Ex-US) regulatory strategy, regulatory submissions, and interactions with global regulatory authorities • Collaborate with functional leaders to create and negotiate optimal development paths for Iovance product candidates • Execute clinical-regulatory development plans on time while managing identified risks • Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments • Ensure submission documents and correspondence meet high standards for content, organization, clarity, and accuracy • Lead cross-functional teams in developing strategic briefing packages and preparing for health authority meetings and interactions • Incorporate evolving global regulations, guidelines, and health authority expectations for biologics and ATMPs, including cell therapy products, into program decisions • Work within the department and with other functional areas on process improvements • Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics • Perform miscellaneous duties as assigned

🎯 Requirements

• BS degree in life sciences required • Minimum 5 years of experience in regulatory affairs with a doctorate degree (ie, MD, PhD, PharmD, or equivalent), 8 years with Master’s Degree, or 10 years with a Bachelor’s degree • Late-stage experience in oncology drug development • Experience creating and negotiating clinical-regulatory aspects of oncology drug development programs with health authorities, including Ex-US • Ability to write, edit, and/or collaborate on high-quality clinical-regulatory documents, including briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries • Ability to write clearly and concisely within agreed timelines • Ability to manage multiple projects and submissions simultaneously, 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 • Ability to influence and negotiate professionally within cross-functional teams and with external partners • Excellent interpersonal, verbal, and written communication skills • Must be able to remain standing or sitting for prolonged periods • Must be able to move about inside an office and exert up to 10 pounds of force occasionally or negligible force frequently or constantly • Visual acuity for preparing and analyzing data and figures, viewing computer screens, and extensive reading • Ability to perform repetitive wrist, hand, and finger motions • Ability to communicate with others to exchange information • Clear and conceptual thinking, judgment, troubleshooting, problem-solving, analysis, discretion, stress management, prioritization, and deadline management