Sr Director, Regulatory Affairs CMC

Kite Pharma•Santa Monica, CA

About The Position

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.

Requirements

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).
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

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