Regulatory CMC Lead — Cell Therapy & LVV (Remote)

Gilead Sciences Inc.; Maryland; Ibrido; USD 143.000 - 185.000; Tempo pieno

Vantaggi offerti da questo lavoro

Relocation to CA

Hybrid work policy (2 days remote)

Descrizione del lavoro

Kite, a Gilead company, seeks a Regulatory CMC leader to guide global regulatory strategies for autologous T-cell and LVV programs. Lead or support IND/CTA submissions, define phase-appropriate content, and collaborate across clinical, manufacturing, and QA teams to align regulatory plans with development goals.

This role emphasizes multi-site development, lifecycle management, and post-approval readiness with strong leadership and health authority engagement experience.

Competenze

• Bachelor's degree and eight years of experience in Regulatory CMC.
• Master's degree with six years of experience in CMC regulatory affairs.
• PhD with two years of experience in biotech/CMC regulatory fields.

Mansioni

• Lead or support integrated global CMC regulatory strategies for cell therapy products.
• Serve as Regulatory CMC representative on program teams; translate decisions into regulatory plans and submissions.
• Define phase-appropriate CMC content and evidence expectations for pivotal studies and filings.
• Provide regulatory input on manufacturing changes, comparability, and site transfers across development programs.
• Support post-approval change strategies and lifecycle management for multi-site products.

Conoscenze

Regulatory CMC experience

Cross-functional leadership

IND/CTA submissions

Biotech/cell therapy

Formazione

Bachelor's degree with 8+ years

Master's degree with 6+ years

PhD with 2+ years

Strumenti

GMP/ICH knowledge

Descrizione del lavoro

Kite, a Gilead company, seeks a Regulatory CMC leader to guide global regulatory strategies for autologous T-cell and LVV programs. Lead or support IND/CTA submissions, define phase-appropriate content, and collaborate across clinical, manufacturing, and QA teams to align regulatory plans with development goals.

This role emphasizes multi-site development, lifecycle management, and post-approval readiness with strong leadership and health authority engagement experience.