Manager, Regulatory Affairs CMC

Kite Pharma, Inc.; Santa Monica (CA); Hybrid; USD 133,000 - 172,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Flexible work policy

Job summary

Kite Pharma, Inc. hires for a Manager, Global Regulatory CMC to lead regulatory CMC submissions and lifecycle management across global CAR‑T programs. The role requires coordinating with Technical Operations, Quality, Process Development and Regulatory teams in US, EU, and other regions.

The position supports global site additions, process changes, and shelf-life extensions, with focus on regulatory strategy and risk mitigation in a fast-paced biopharma setting.

Qualifications

• Bachelor’s degree required; six years’ regulatory CMC/drug development experience or Master’s degree with four years’ experience.
• Experience with FDA/EMA and global regulatory requirements for biologics or cell/gene therapies preferred.
• Autologous CAR‑T or ATMP experience is strongly preferred.

Responsibilities

• Lead regulatory CMC submissions (INDs, IMPDs, BLAs, MAAs) for global CAR‑T programs.
• Serve as Regulatory CMC lead on program teams; coordinate Module 3 content across regions.
• Develop and execute CMC regulatory strategies; manage changes and lifecycle activities.
• Identify risks, plan mitigations, and prepare regulator briefing packages.

Skills

Regulatory CMC leadership

Written and verbal communication

Project and cross-functional teamwork

Regulatory strategy

Regulatory risk management

Microsoft Office suite (Word, Excel, P

Education

Bachelor’s degree in a scientific discipline

Master’s degree in a scientific discipline

Job description

## Manager, Regulatory Affairs CMCApply: Onsite - Hybrid Eligible: United States - California - Santa Monica: United States - California - Foster City: United States - California - Thousand Oaks: United States - California - El Segundo: Full time: Posted 2 Days Ago: R0055525We’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## 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.***Kite is transitioning from its current Santa Monica headquarters, with employees expected to relocate to our Thousand Oaks, CA, Foster City, CA 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.***## **Key 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## ## **Basic Qualifications**Bachelor’s degree and Six Years' experienceORMaster's degree and Four Years' experience ## **Preferred Qualifications*** A 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 and Competencies*** 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. 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: $133,195.00 - $172,370.00. 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.