Sr Director, Regulatory Affairs 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

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

The Senior Director, Regulatory CMC – CAR T Cell Therapy provides global leadership and strategic direction for CMC regulatory activities across early  and late stage development through commercialization of autologous CAR T cell therapy products. This role is accountable for setting and executing global CMC regulatory strategies, leading complex submissions, managing lifecycle changes, and serving as a senior regulatory authority and advisor to cross functional leaders.

The role partners closely with Technical Operations, Manufacturing, MSAT, Process & Analytical Development, Quality, Global Regulatory Affairs, and external partners to enable compliant, efficient development and supply of CAR T products across regions.

Key Responsibilities

Global CMC Regulatory Strategy & Leadership

• Define and lead global CMC regulatory strategy for CAR‑T programs across early and late clinical development and post‑approval lifecycle management.

• Anticipate evolving global expectations for ATMPs/CAR‑T and proactively assess regulatory risks, opportunities, and mitigation strategies.

• Represent Regulatory CMC as a senior leader on cross‑functional governance and core teams.

Regulatory Submissions & Agency Engagements

• Provide executive oversight and critical review of Module 3 / Quality content for clinical and commercial applications.

• Ensure end‑to‑end consistency, scientific rigor, and regulatory defensibility of CMC dossiers, including in‑context review of compiled applications and health‑authority responses (e.g., RTQs, IRs).

• Serve as a senior CMC subject‑matter expert for health authority interactions, including briefing documents and participation in agency meetings.

Change Management & Lifecycle Strategy

• Lead global CMC regulatory assessments for manufacturing and control changes, including process evolution, site transfers, comparability strategies, analytical changes, and shelf‑life updates.

• Drive lifecycle strategies that balance regulatory compliance, technical feasibility, supply continuity, and business objectives.

• Oversee complex global LCM planning, including sequencing, regional differences, and submission pathways.

Technical & Cross‑Functional Partnership

• Provide strategic regulatory guidance to technical teams throughout product development, scale‑up, validation, and commercialization.

• Partner closely with Manufacturing, MSAT, Quality, and external CDMOs to ensure regulatory‑compliant execution.

• Review and provide oversight of CMC components supporting labeling, product information, and related regulatory documents.

Leadership, Talent & Operational Excellence

• Lead, develop, and mentor a team of Regulatory CMC leaders and/or provide strong matrix leadership across programs.

• Set priorities and oversee resources, and timelines for a complex portfolio of submissions and lifecycle activities.

• Contribute to the advancement of Regulatory CMC capabilities, processes, and best practices globally.

• Senior influencer internally and externally on CMC regulatory topics for advanced therapies

Education & Experience

• 14 years of biopharmaceutical industry experience, including extensive Regulatory CMC leadership with a bachelor's degree or 12 years with a master's degree.

• Advanced degree preferred (PhD, PharmD, MS, or equivalent) in a scientific discipline.

• Deep experience with cell therapy and/or gene therapy products; CAR‑T experience strongly preferred.

• Demonstrated success leading global CMC strategies and major submissions (e.g., late‑stage clinical, BLA/MAA, post‑approval supplements).

• Strong knowledge of ICH guidelines, ATMP regulations, and global CMC expectations (FDA, EMA, and key international markets).

Key Competencies

• Strategic and systems thinking with strong regulatory risk assessment skills

• Executive‑level written and verbal communication

• Ability to influence senior leaders and cross‑functional stakeholders

• Sound judgment in complex, ambiguous regulatory environments

• Proven people leadership and talent development

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: $221,000.00 - $286,000.00. 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 jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.