RA associate

תיאור התפקיד

Gamida Cell Ltd. is a clinical stage biopharmaceutical company developing cell therapies that are designed to treat cancer and rare, serious hematologic diseases. An ongoing global, pivotal phase III study of NiCord in patients with hematologic malignancies is expected to read out in 2020.
1. Critical review of development reports, review of validation reports, stability reports, pre-clinical and clinical protocols and reports which are part of regulatory submissions
2. Summarize, compile and review of documents to prepare regulatory submissions and dossiers
3. Manage preparation of submission files, including coordination of input and review by different functional teams and consolidation of their feedback, maintaining high quality and adherence to timelines
4. Review and write controlled documents and SOPs related to regulatory activities


דרישות התפקיד

Candidate’s background
• Bachelor’s degree in a Life Sciences related field (Biology/Biotechnology/Medical Sciences) or B.Pharm
• Minimum 2 years of global RA experience in pharmaceutical/biopharmaceutical industry, including quality and clinical aspects
• Experience with managing of global registration of new investigational products
• Experience with various submissions to FDA, EMA and local EU authorities
• Understanding and knowledge of FDA and EMA regulatory guidelines for human drugs
• Good scientific understanding and deduction capabilities
• Basic knowledge of GMP and GCP principles
• Technical and regulatory writing skills
• Excellent verbal and written communication skills in English
• Meticulous and paying attention to details
• Good knowledge in Microsoft Office
• Team player, strong analytical skills and ability to work with a minimal supervision, under pressure and meet deadlines
• Good personal communication and interaction capabilities
• Advantage: MSc degree in biology/biotechnology, experience and knowledge in cell therapy

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