Senior Manager, Regulatory Affairs

Company: Kite Pharma
Location: Santa Monica
Posted on: August 23, 2020

Job Description:

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 jobJob DescriptionGlobal Regulatory Affairs at Kite Pharma, a Gilead Company, develops innovative global/regional regulatory strategies and filings that will advance novel medicinal oncology products for patients. Our robust cell therapy pipeline has paved the way for exceptional expansion!The Senior Manager, Regulatory Affairs will work in a matrix environment and possess the credentials to be the US lead in providing both strategic input and day to day guidance for the projects assigned.Are you ready to make a significant impact on novel regulatory strategies in a dynamic environment? Come join us in our mission to cure cancer!Responsibilities (include but are not limited to):Provide regulatory guidance to cross-functional teams ensuring the project assigned progresses from IND stage to launch within company agreed timelines.Capable of critically reviewing complex technical documents and influencing colleagues across functionsParticipate in cross functional teams and manage the preparation of applications and subsequent US-based regulatory documents, pre and post approval in accordance with agreed timeframesPrepare and/or manage submissions that are technically complex and ensure submission-readiness of all regulatory documents related to the projectEnsure that documents to be submitted to the health authorities are compliant with US eCTD submission requirements.Assist and mentor in developing junior regulatory affairs staff.Build long term effective relationships and open communication with cross functional teams in order to provide accurate information and timeframes.Maintain current knowledge of relevant regulations, including proposed and final rulesRequirements:Minimum of BA/BS + 8 years; MS + 6 years; or PhD/PharmD and 4 years of relevant US regulatory (FDA) / drug development experienceAdditional Qualifications:Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficienciesExcellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentWillingness to think outside of the box and adapt best practicesAbility to adapt in a constantly evolving environmentSelf-motivated with a strong sense of ownership in areas of responsibilityHigh degree of professionalism, ethics and integrityComfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities#IND123Kite 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 . Sign up to follow @KitePharma on Twitter at .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--careers@gilead.com--for assistance.For more information about equal employment opportunity protections, please view the--'EEO is the Law'--poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.Full time

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