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Director, Regulatory Affairs

United States - California - Santa MonicaRegulatoryRegular

Job Description

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 Director, Regulatory Affairs is a product-facing role that provides regulatory leadership in support of the development programs. This includes the development and implementation of regulatory strategy working in a multi-functional setting, ensuring timely preparation through collaboration with other functions, review and submission of documents to regulatory authorities, and maintaining compliance. This person represents the regulatory function on multi-disciplinary teams and will integrate company goals into the objectives and activities of the department, as well as product teams.

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 required 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 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) and/or US Regulatory Lead (USRL) for assigned Regulatory Project Teams in the development of global strategies and advise the in the development of applicable strategies and execution of 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 work 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

Requirements:

  • Minimum BS degree in related life science discipline and 12+ years of relevant experience required OR
  • MS/MA/MBA education and 10+ years of relevant experience OR
  • PharmD/PhD education and 8+ years of relevant experience OR
  • HS Diploma and 16+ years of relevant experience

Additional Qualifications:

  • MS, PhD or PharmD in a scientific discipline preferred
  • Knowledge and understanding of global regulations and guidelines
  • Prior experience in setting global regulatory strategy for early development programs  
  • 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 is highly desirable (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 desired
  • Ability to work in a cross-functional team environment with experience managing people and project teams
  • Strong attention to detail and the ability to prioritize 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