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 Director, Regulatory Affairs is a product-facing role that provides regulatory leadership in support of the 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. This person represents 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 7 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.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Kite Pharma, Inc.