Manager, Regulatory Affairs CMC

Описание вакансии

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 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 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

• 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 in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field) with 6 years of relevant Regulatory CMC and/or drug development experience, including direct experience with FDA‑regulated products or a master's degree in related scientific discipline and 4 years of relevant experience as listed above.

• Experience supporting biologics and/or cell or gene therapy products is strongly preferred

Preferred Qualifications

• 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