Manager, Regulatory Affairs CMC

Kite Pharma•Santa Monica, CA

1d•Hybrid

About The Position

At Kite, our mission is to cure cancer. We are dedicated to developing innovative treatments and making significant advances in cancer therapies. As a people leader, you will be instrumental in shaping our culture, creating an inclusive environment, and empowering employees to achieve their aspirations. Join us in our pursuit of a healthier world and help create more tomorrows. The Manager, Global Regulatory CMC will support Kite’s autologous CAR T cell therapy portfolio, providing regulatory CMC leadership for global clinical development and commercial expansion across multiple regions. This role is responsible for CMC regulatory submissions, lifecycle management, and change management in alignment with global regulatory strategy and business objectives. The individual will serve as a key Regulatory CMC representative on cross functional program teams, partnering closely with Technical Operations, Quality, Process Development, Analytical, Manufacturing, and Global Regulatory Affairs. Located in Santa Monica, CA (onsite/hybrid).

Requirements

Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field) with 6 years of relevant Regulatory CMC and/or drug development experience, including direct experience with FDA‑regulated products or a master's degree in related scientific discipline and 4 years of relevant experience as listed above.
Experience supporting biologics and/or cell or gene therapy products is strongly preferred
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)

Nice To Haves

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

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