Head of Regulatory & Quality Strategy (Hybrid)

Regulatory Jobs; South San Francisco (CA); Hybrid; USD 351,000 - 388,000; Full time

Job summary

Pliant is seeking a Vice President, Regulatory Affairs & Quality to lead an integrated global regulatory and quality function for oncology programs, including an IND/CTA enabled portfolio. The role is hybrid (3 days onsite in South San Francisco) and requires building scalable processes across GLP, GCP, GVP and GMP to enable rapid, compliant early-phase clinical development.

The candidate will partner with clinical, CMC, biometrics and translational teams, interface with FDA, and drive strategic

Qualifications

• Bachelor's degree in a scientific field required; advanced degree preferred.
• 15+ years of regulatory and/or quality experience in biotech/pharma, including oncology drug development.
• 8+ years of leadership experience with direct accountability for team performance.
• Experience leading INDs/CTAs filings and regulatory strategy for early-phase oncology assets.
• Direct interface with FDA and global health authorities.

Responsibilities

• Develops and executes global regulatory strategy for oncology programs across development lifecycle.
• Leads preparation, review, and submission of regulatory filings (INDs/CTAs).
• Serves as primary agency contact with FDA and other authorities for regulatory discussions and inspections.
• Advises on oncology regulatory pathways (Fast Track, Breakthrough Therapy, Orphan Drug, Accelerated Approval).
• Oversees Quality function (GLP, GCP, GVP, GMP) for Phase 1/2 program.
• Manages CRO/CMO audits and quality agreements with partners.
• Builds and scales regulatory and quality infrastructure to support rapid, compliant early trials.
• Provides cross-functional regulatory input for labeling, publications and disclosures.
• Leads department planning, headcount, budgeting and systems for regulatory/quality.
• Leads, coaches, and develops leadership team in a lean organization.

Education

Bachelor's degree in scientific field

Advanced degree (PhD, PharmD, MS) preferred

Tools

IND/CTA filings

Job description

Pliant is seeking a Vice President, Regulatory Affairs & Quality to lead an integrated global regulatory and quality function for oncology programs, including an IND/CTA enabled portfolio. The role is hybrid (3 days onsite in South San Francisco) and requires building scalable processes across GLP, GCP, GVP and GMP to enable rapid, compliant early-phase clinical development.

The candidate will partner with clinical, CMC, biometrics and translational teams, interface with FDA, and drive strategic