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.

As a Director, Global Regulatory Affairs CMC, at Gilead you will...be responsible for providing global regulatory CMC leadership and strategy across the development, lifecycle management, and commercialization of cell therapy and viral vector–based 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