Director, Regulatory Affairs CMC

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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.

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 worlds 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.

As a Director Global Regulatory Affairs CMC at Gilead you responsible for providing global regulatory CMC leadership and strategy across the development lifecycle management and commercialization of cell therapy and viral vectorbased products. This role leads the development compilation review and maintenance of CMC sections (Quality Module Module 3) for global regulatory submissions including clinical trial applications marketing applications health authority responses and post-approval filings.

The Director serves as a key strategic interface between Global Regulatory Affairs Research Technical Operations Quality and external partners and provides expert guidance on global CMC regulatory requirements change management and risk mitigation across product lifecycles.

Kite is transitioning from its current Santa Monica headquarters with employees expected to relocate to our Oceanside Thousand Oaks El Segundo or Foster City 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

Global Regulatory CMC Strategy & Leadership

• Provide independent strategic regulatory CMC leadership for investigational and commercial products with a focus on cell therapy and viral vector platforms.

• Represent Regulatory CMC on and/or lead cross-functional and matrix teams supporting development commercialization and lifecycle management activities.

• Align global CMC regulatory strategies with overall regulatory technical and business strategies.

• Anticipate regulatory trends paradigm shifts and emerging expectations and proactively communicate risks and opportunities to stakeholders.

Regulatory Submissions & Health Authority Interactions

• Lead and oversee preparation critical review and submission of global CMC regulatory dossiers ensuring accuracy completeness consistency and timeliness.

• Serve as a key regulatory CMC contact for health authority interactions including CMC-related questions responses briefing documents and participation/leadership in agency meetings.

• Ensure global harmonization of CMC content across submissions (e.g. Module 3 alignment across regions and applications).

Change Management & Risk Assessment

• Assess manufacturing change controls (process raw materials facilities equipment analytical methods shelf life etc.) for global regulatory impact.

• Identify CMC regulatory risks and develop mitigation strategies including scenario planning and contingency plans.

• Provide regulatory assessments and recommendations to support decision-making for complex or high-impact changes.

Technical & Cross-Functional Collaboration

• Guide technical teams on global CMC regulatory requirements throughout development and post-approval stages.

• Partner closely with Tech Ops Quality MSAT Manufacturing and external collaborators to ensure regulatory-compliant execution.

• Participate in product fact-finding meetings due diligence activities and evaluation of new programs or technologies.

Operational Excellence & Systems

• Independently manage and prioritize multiple complex programs and submissions.

• Utilize electronic regulatory systems for dossier development document management and submission tracking.

• Contribute to the development and maintenance of regulatory strategy documents templates and best practices.

Qualifications

Education

• 12 years experience with a BA/BS degree or 10 years of relevant experience with a masters degree. 8 years with a PhD (or equivalent education) in a scientific or related discipline.

Experience

• Minimum 10 years of pharmaceutical/biotechnology industry experience including 7 years in Regulatory Affairs CMC.

• Strong experience with cell therapy and/or viral vectorbased products; ATMP experience strongly preferred.

• In-depth knowledge of global CMC regulatory requirements across development and post-approval phases.

• Demonstrated expertise in biopharmaceutical development including drug substance/drug product manufacturing sterile products and analytical methods.

• Solid understanding of ICH guidelines cGMP requirements and global regulatory expectations.

• Proven experience supporting regulatory inspections and health authority engagements.

• Demonstrated ability to author and critically review complex CMC sections and to lead CMC sub-teams.

Key Competencies

• Strategic thinking with strong risk assessment and problem-solving skills.

• Excellent written verbal and negotiation skills.

• Ability to operate independently and lead in a fast-paced evolving environment.

• Strong leadership and collaboration skills across functions and geographies.

• High level of accountability ownership and adaptability.

• Ability to manage multiple priorities and complex timelines with minimal oversight.

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: $191250.00 - $247500.00. 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:

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at 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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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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.

Please apply via the Internal Career Opportunities portal in Workday.