Sr Regulatory Affairs Associate, CMC

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

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

Responsibilities (include but are not limited to):

• 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

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