Senior Manager, Regulatory Affairs

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Nov 13, 2020
Ref
R0013948
Required Education
Doctorate/PHD/MD
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

Global 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 functions
  • Participate in cross functional teams and manage the preparation of applications and subsequent US-based regulatory documents, pre and post approval in accordance with agreed timeframes
  • Prepare and/or manage submissions that are technically complex and ensure submission-readiness of all regulatory documents related to the project
  • Ensure 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 rules


Requirements:
  • PhD with 4+ years of Regulatory Affairs experience OR
  • MS with 6+ years Regulatory Affairs experience OR
  • BS with 8+ years of Regulatory Affairs experience OR
  • Associate's Degree with 10+ years of Regulatory Affairs experience OR
  • High School Diploma with 12+ years of Regulatory Affairs experience


Additional Qualifications:
  • Advanced technical degree preferred
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Willingness to think outside of the box and adapt best practices
  • Ability to adapt in a constantly evolving environment
  • Self-motivated with a strong sense of ownership in areas of responsibility
  • High degree of professionalism, ethics and integrity
  • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities


#IND123

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.