Job DescriptionKite 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
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.
The salary range for this position is: $115,260.00 - $149,160.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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.
For Current Kite Pharma Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.
