Fate Therapeutics Inc. is a biotechnology company headquartered in San Diego CA, developing first-in-class therapeutics with novel points of intervention in the field of adult stem cell biology. The Company’s first clinical program, ProHema, pioneers an innovative therapeutic modality and consists of ex vivo pharmacologically-modulated hematopoietic stem cells designed to enhance hematopoietic reconstitution in patients undergoing stem cell transplant. In addition, Fate Therapeutics has a robust preclinical pipeline of first-in-class in vivo stem cell modulators for skeletal muscle regeneration. To advance its discovery and development efforts, the Company applies its award-winning, proprietary, induced pluripotent stem cell technology to generate rare cell populations and model disease. For more information, please visit www.fatetherapeutics.com.
Fate Therapeutics is seeking a motivated individual to join the Regulatory Affairs team. The position is based at the Company’s corporate headquarters in San Diego and will report to the Senior Vice President, Clinical Development. This position is a key member of project development teams, and is responsible for the evaluation of product development concepts from the regulatory perspective. Fate’s lead clinical program involves a novel hematopoietic stem cell therapy. The ideal candidate should have experience in the area of biologic cellular therapy and antibody product development including complex submissions to FDA and ex-US health authorities. Knowledge and awareness of the pertinent regulations and how they apply to this rapidly evolving field are important. The candidate should have a track record of relevant experience gained in an equivalent industry position.
Major Responsibilities Include:
- Serve as the Company’s representative with regulatory health authorities on assigned development projects
- Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing regulatory solutions and feedback on the ongoing project development; work closely with development team to troubleshoot technical issues related to regulatory submissions
- Lead the coordination, gathering of information, and review of reports, protocols, documents for regulatory submissions; ensure consistent and appropriate regulatory guidance and communication within the development organization
- Establish and meet timelines for regulatory submission activities to ensure commitments are met; review documents for submission to regulatory agencies to assure accuracy, quality, content and format, and compliance with applicable regulations
- Provide the regulatory plan for assigned project and review the overall product development plan to ensure alignment of development activities in support of regulatory registration plan; maintain awareness and communicate with development team members regarding changing regulatory requirements; provide updates on revised/new regulations and guidance documents and to assess impact on the product development plan
- Develop a plan and oversee the establishment of required regulatory affairs operational infrastructure to support ongoing (Phase 2/ 3) regulatory activities, includes SOP development and implementation of electronic submission/filing solutions while working closely with the Manager, Regulatory Operations and Document Control
- Manage regulatory expedited safety reporting for development projects
- Plan and support IND/BLA filings or other major regulatory interactions, including coordination of FDA or ex-US meeting materials (meeting requests, briefing documents, presentation materials)
- Interact with outside consulting groups and manage activities, as necessary for completing key regulatory initiatives
BioSpace.com - 11 months ago