Manager, Regulatory Affairs

Kite Pharma•Foster City, CA

1d•$133,195 - $189,640•Hybrid

About The Position

Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our El Segundo/Thousand Oaks office beginning in January 2027. While this role will be based in Santa Monica through 2026, applicants should take this planned relocation into consideration. Kite supports a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. This role may also be located at our Foster City location with a flexible working policy, offering a balanced approach with two days of remote working and three days working onsite. 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.

Requirements

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 have in-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
Is recognized as a knowledgeable resource within the department on a range of topics.
Work is performed under minimal direction of a senior Regulatory Affairs professional.
BS and 7+ year of experience in Regulatory Affairs or other relevant industry experience OR MS and 5+ years of experience in Regulatory Affairs or other relevant industry experience
Degree in a scientific field is preferred.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Responsibilities

Responsible for preparing regulatory submissions which require interactions 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 submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations), original, marketing authorization applications for territories other than the US and EU and for contributing to preparation of US and EU marketing authorizations).
Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics.
Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling.
May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses.
Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects.
Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge.
Initiates or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.