Sr Regulatory Affairs Associate, CMC

Kite Pharma•Santa Monica, CA

1d•$115,260 - $149,160•Hybrid

About The Position

Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Oceanside, Thousand Oaks, or El Segundo, CA 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. 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

BA/BS degree with 5 years of relevant experience in Regulatory Affairs CMC and/or biopharmaceutical industry or 3 years of relevant experience with a master's degree
Some knowledge of ICH requirements, and an understanding of current global trends in CMC Regulatory Affairs
Organizational skills – detail oriented and able to adapt to frequent changes in product activity
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
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
People Leader Accountabilities: •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 moderately complex regulatory submissions which require interactions with departments outside of Regulatory Affairs CMC for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures
Supports operational and life cycle management of regulatory CMC submissions in support of global commercial and clinical programs.
Identify CMC risk areas and suggest alternative scenarios and course of action
May act as Regulatory CMC representative on cross functional project teams by applying knowledge of regulations and interprets technical regulatory guidelines to ensure that regulatory submissions are in compliance with applicable regulations
May be responsible for ensuring that CMC-specific registered technical details are updated and maintained
Responsible for development and acquisition of required regulatory skills and knowledge, under guidance of immediate manager
May initiate or contribute to local process improvements as they relate to Regulatory Affairs CMC function
May perform regulatory assessments for change controls and supplier notification within the Quality Management System to determine regulatory impact, reporting category, and submission requirements
Responsible for managing Regulatory CMC Commitments made to Health Authorities
Responsible for supporting Annual Product Review or Vector Product Review for all products
Participates in group meetings and presents project status updates and strategic approaches to moderately complex programs