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Regulatory Affairs Manager
Office: Kiryat Gat, Israel
- Company: Gamida Cell, Ltd.
- Posting Title: Regulatory Affairs Manager
- Function: RA
- Reports to: RA Director
Gamida Cell is a leader in advanced cellular therapies and hematopoietic stem cell transplantation, with two FDA approved therapies, Omisirge® (omidubicel-onlv) and APHEXDA® (motixafortide). Omisirge® is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy that is potentially curative for patients with hematologic malignancies. APHEXDA® is a CXCR4 antagonist with long receptor occupancy indicated in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.
General Scope and Summary
The Regulatory Affairs Manager is responsible for leading and executing regulatory activities to support the development, registration, and lifecycle management of chemical, biological and cell therapy products in the US. This role ensures compliance with global regulatory requirements and works cross-functionally with internal teams (R&D, Clinical, QA/QC, Manufacturing, marketing) and external stakeholders to coordinate the preparation, submission, and maintenance of regulatory documentation. The manager contributes to regulatory strategy implementation, risk assessment of proposed changes, and acts as a subject matter expert on regulatory standards and guidelines issued by health authorities including the FDA.
Roles and Responsibilities
- Coordination, preparation, and submission of the regulatory documents per regulatory strategy, for Health Authorities in US and Ex-US in cooperation with other departments in GC (R&D, Mfg. / Ops, Clinical, QA/QC, marketing) under the guidance of manager.
- Planning, preparation, and submission of responses to questions from Health Authorities under the guidance of manager.
- Electronic submissions to the FDA in cooperation with relevant outsourced agents.
- Assessment of regulatory implications of CMC/labeling planned changes.
- Identifying, understanding and implementation of the regulatory requirements for labeling and CMC aspects of chemical, biological and cell therapy products in US.
- Preparing, updating, and reviewing company SOPs.
- Compiling and maintenance of internal regulatory documentation database.
- Making recommendations regarding regulatory issues.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Providing technical review of data or R&D reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Representing RA in Change Review Board meetings and project related meetings.
Experience, Education and Specialized Knowledge and Skills
- Bachelor’s degree in Life Sciences related field (Biology/Biotechnology/Medical Sciences or equivalent) or B. Pharm.
- Minimum 5 years of global RA experience in pharmaceutical/biopharmaceutical industry, including quality and labeling aspects.
- Experience with maintaining BLA/NDA lifecycle in eCTD format.
- Experience with various submissions to FDA, including CMC, periodic reports and response to Information Requests.
- Understanding and knowledge of FDA regulatory guidelines for human drugs.
- Good scientific understanding and deduction capabilities
- Knowledge of GMP and GCP principles
- Technical and regulatory writing skills
- Demonstrate organization and communication skills
- Meticulous and paying attention to details
- Good knowledge in Microsoft Office
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