Manager, Regulatory Affairs CMC

Kite is dedicated to curing cancer through pioneering personalized CAR T‑cell therapies. This role supports Kite’s autologous CAR T cell therapy portfolio, providing regulatory CMC leadership for global clinical development and commercial expansion across multiple regions. The position is based in Santa Monica, CA through 2026, with a planned relocation to Thousand Oaks, CA, Foster City, CA, or El Segundo, CA beginning January 2027. Kite offers a flexible working policy with two days remote and three days onsite per week.

Responsibilities

• Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting global clinical and commercial CAR‑T programs
• Serve as the Regulatory CMC lead on assigned program and/or platform teams, applying advanced knowledge of global CMC regulatory requirements for autologous cell therapies
• Author, review, and coordinate Module 3 (M3) content, ensuring global alignment and harmonization across regions (US, EU, and other international health authorities)
• Develop and execute CMC regulatory strategies that align with overarching regulatory and business strategies, including support for global site additions, process changes, raw material changes, analytical updates, and shelf‑life extensions
• Proactively identify CMC regulatory risks and lead scenario planning, including anticipation of regulator questions and development of mitigation and contingency plans
• Assess and provide regulatory impact evaluations for CMC changes through formal change control processes, ensuring appropriate global regulatory strategies are defined and executed
• Support interactions with global health authorities by contributing to briefing packages, written responses, and regulatory meeting preparations specific to CMC topics
• Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines
• Support continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment

Qualifications

Basic Qualifications

• Bachelor’s degree and six years’ experience, OR Master’s degree and four years’ experience, OR PhD

Preferred Qualifications

• Degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field)
• 5+ years of relevant Regulatory CMC and/or drug development experience, including direct experience with FDA‑regulated products
• Experience supporting biologics and/or cell or gene therapy products is strongly preferred
• Experience with autologous CAR‑T cell therapy or advanced therapy medicinal products (ATMPs)
• Working knowledge of global regulatory requirements (FDA, EMA, and other international agencies)
• Experience supporting both clinical development and commercial lifecycle management

Skills

• Strong written and verbal communication skills, with the ability to translate complex CMC topics for diverse stakeholders
• Highly organized, detail‑oriented, and comfortable managing multiple priorities in a fast‑paced environment
• Demonstrated ability to operate effectively in cross‑functional, matrixed teams
• Self‑motivated with a strong sense of ownership, accountability, and follow‑through
• Ability to adapt quickly to evolving regulatory landscapes and business needs
• High degree of professionalism, integrity, and ethical conduct
• Proficiency with standard business software tools (e.g., MS Word, Excel, PowerPoint, Adobe)

Work Environment

• Fast‑paced, collaborative biotechnology environment
• Requires flexibility, adaptability, and a proactive, solution‑oriented mindset
• Minimal day‑to‑day supervision with high expectations for independent judgment and initiative

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; ensure employees receive 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; provide the support needed to remove barriers and connect their team to the broader ecosystem

Pay

Salary range: $133,195.00 – $172,370.00 per year. Actual compensation varies based on experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), and paid time off.

Benefits

• Company‑sponsored medical, dental, vision, and life insurance plans
• Additional benefits information available at https://www.gilead.com/careers/compensation-benefits-and-wellbeing

Location & Schedule

• Based in Santa Monica, CA through 2026; planned relocation to Thousand Oaks, CA, Foster City, CA, or El Segundo, CA beginning January 2027
• Flexible working policy: two days remote, three days onsite per week