Executive Director, Regulatory Affairs

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Sep 27, 2020
Ref
R0015557
Required Education
Bachelors Degree
Position Type
Full time

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Worldwide Cell Therapy, 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 Executive Director, Regulatory Affairs is a product-facing role that provides regulatory leadership in support of our approved CAR-T therapies, YESCARTA, Tecartus, and other early development programs at Kite. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and ensuring compliance with applicable regulatory requirements. The incumbent will lead direct reports, represent the function on multi-disciplinary teams, and must integrate company goals into the objectives and activities of the Regulatory Affairs Department.

Are you interested in serving as a resource to team members for regulatory requirements to conduct drug development activities for cell and gene therapy products? Come join us in our mission to cure cancer!

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 to form global strategies and advise the US Regulatory Lead (USRL) in the development of US regulatory approaches and execution of US filings
  • Supervise, analyze, and disseminate intelligence on 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 collaborate with regulatory authorities; be primary liaison for day-to-day interactions
  • Coordinate 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

 


Requirements:

 

 

  • BS/MS with at least 16 years of meaningful experience, or MS/PhD/PharmD or related advanced degree in a scientific discipline along with at least 14 years of Regulatory Affairs related industry experience

 


Additional Qualifications:

 

 

 

  • Knowledge and understanding of global regulations and guidelines
  • 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.