Regulatory Senior Manager Cell Therapy Program
6 days ago
For Current Kite Pharma Employees and Contractors:
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**Job Description**:
Specific Education & Experience Requirements:
8+ years of experience in Regulatory Affairs or other relevant industry experience
Degree in a scientific field is preferred.
Specific Job Responsibilities:
Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
Responsible for preparation of the Company Core Data Sheets (CCDS) for assigned products, and ensures that any updates to the CCDS and the Product Company Core Safety Information (CCSI) are implemented.
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license.
Acts as project team representative for specified products depending on complexity of the project.
May provide strategic regulatory advice as appropriate.
Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information to project teams and senior management in a timely manner.
May contribute to training of staff under direction of Senior Regulatory Affairs Professional.
May initiate local process improvements and contribute to local and / or global process improvements, which have a moderate impact on the Regulatory Affairs function or other departments.
Plans, schedules and arranges own activities and may direct others in accomplishing objectives.
Excellent organization skills and ability to work on a number of projects with tight timelines is required.
Excellent verbal and written communication skills and interpersonal skills are required.
Must be knowledgeable of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
Must be capable of developing and implementing regulatory strategy and of managing negotiations with Regulatory Authorities.
May take a leadership role in updating and preparing the Company for minor changes in legislation in assigned territories.
Must be capable of leading a small team in preparation of submissions.
Work is performed under limited direction of a senior Regulatory Affairs professional. Is recognized as a knowledgeable resource for Regulatory Advice on specific topics in other departments.
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
For Current Kite Pharma Employees and Contractors:
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Internal Career Site
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