Vice President, CMC Regulatory Affairs

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September 24

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Iovance Biotherapeutics, Inc.

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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.

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Leads the development and implementation of all CMC regulatory strategy to support global development programs and market applications for cell therapies • Responsible for ensuring the appropriate execution of CMC regulatory strategy • Provide strategic and operational leadership and ensure effectiveness of the CMC Regulatory Affairs team • Lead preparation of CMC-related submission planning, risk assessments, and ensure high-quality, accurate submission documents completed within target timelines • Build and manage relationships with internal and external stakeholders and work across functions • Ensure CMC dossiers meet ICH format and local country requirements; stay current with regulatory requirements and initiate process improvements • Analyze complex CMC issues, interpret and discuss data with cross-functional teams and health authorities

🎯 Requirements

• Experience in biologics drug development, market applications and commercial lifecycle • Bachelor’s degree in life sciences required • 20+ years of pharmaceutical / biopharmaceutical industry experience • 15+ years of relevant biologics experience in Regulatory Affairs CMC • Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA • Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions • Extensive regulatory management experience and in developing innovative regulatory solutions • Ability to motivate and lead others • Excellent interpersonal, verbal and written communication skills and ability to effectively lead and influence others • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities • Advanced degree preferred (PhD, MD, MD/PhD)