Director, Regulatory Affairs CMC

Director, Global Regulatory Affairs CMC

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

• 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.

• 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).

• 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.

• 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.

• 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

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

• Minimum 10+ years of pharmaceutical/biotechnology industry experience, including 7+ years in Regulatory Affairs CMC.
• Strong experience with cell therapy and/or viral vector–based 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.

• 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: $191,250.00 - $247,500.00. 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.