For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
Global Regulatory Affairs at Kite Pharma, a Gilead Company, is responsible for developing innovative global/regional regulatory strategies and filings that will advance novel medicinal oncology products for patients.
The Senior Director, Regulatory Affairs/Global Regulatory Lead is a product-facing role that provides regulatory leadership in support of YESCARTA and other early development programs at Kite Pharma. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. The incumbent will lead direct reports, represent the regulatory function on multi-disciplinary teams, and must integrate company goals into the objectives and activities of the Global Regulatory Affairs Department. The successful candidate will serve as a resource to team members for the regulatory requirements to conduct drug development activities for cell and gene therapy products.
Responsibilities (include but are not limited to):
Develop and implement regulatory product strategies
Represent the regulatory function on cross-functional development teams
Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies
Plan, prepare, and review submissions to regulatory authorities including FDA, EMA and other national authorities to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA) throughout the lifecycle of assigned projects
Lead and oversee regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
Serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams in the development of global regulatory strategies and advise the US Regulatory Lead (USRL) in the development of US regulatory strategies and execution of US regulatory filings
Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
Provide interpretation of and advice regarding regulations, directives, and guidance
Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to-day interactions
Coordinate and prepare responses to requests for information from regulatory authorities
Train, manage, and mentor other regulatory affairs personnel
Work externally to engage in regulatory policy initiatives
Other duties as assigned
PhD or PharmD in a scientific discipline preferred along with at least 8 years of experience in industry related Regulatory Affairs (or BS/MS with at least 10 years of relevant experience)
Knowledge and understanding of global regulations and guidelines
Previous experience in the preparation and submission of regulatory documents
Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
Experience with investigational drugs, including late stage development, and marketed products
Ability to work in a cross-functional team environment with experience managing people and project teams
Strong attention to detail and the ability to handle multiple tasks
Excellent organizational, computer and documentation skills and an ability to prioritize effectively
Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Kite Pharma, Inc.