Regulatory & Quality Leader, Oncology (GxP)

Pliant Therapeutics, Inc.; South San Francisco (CA); Hybrid; USD 351,000 - 388,000; Full time

Benefits offered by this job

Hybrid work schedule

Job summary

Pliant Therapeutics, Inc. in South San Francisco, CA, seeks a dynamic Vice President of Regulatory Affairs & Quality (GxP) to lead global regulatory and quality oversight for an oncology portfolio.

This senior leader role partners with the COO and executive team to design scalable GxP infrastructure supporting early-phase trials and potential late-stage development. The role requires deep regulatory and quality expertise, a track record with INDs/CTAs, and strong agency engagement.

Qualifications

• Bachelor's degree in a scientific field required; advanced degree preferred.
• 15+ years of progressive regulatory affairs/quality experience in biotech/pharma.
• 8+ years of senior leadership/management experience.
• Experience leading INDs/CTAs and regulatory filings with direct ownership.
• Hands-on agency interactions with FDA and other global authorities.
• Working knowledge of GLP, GCP, GVP and GMP in a development setting.
• Experience with oncology regulatory designations (Fast Track, Breakthrough, Orphan, Accelerated).
• Vendor management with CROs/CMOs; audits and quality agreements.
• Ability to travel ~15–20% as needed.

Responsibilities

• Develops and executes global regulatory strategy for oncology candidates across development.
• Leads day-to-day regulatory filings preparation and submission with cross-functional teams.
• Serves as primary agency contact for FDA and global health authorities.
• Advises executive team on regulatory pathways and accelerated programs.
• Oversees a risk-based Quality Management System (QMS) and compliance activities.
• Leads quality audits of CROs/CMOs and third-party vendors.
• Negotiates quality agreements and dashboards to monitor compliance.
• Guides pharmacovigilance input and regulatory labeling considerations.

Skills

Regulatory strategy & leadership

Quality Management System (QMS)

FDA/health authority interactions

IND/CTA submissions

GxP regulatory compliance

Oncology regulatory experience

Strategic planning & execution

Vendor management (CROs/CMOs)

Regulatory operations oversight

Education

Bachelor's degree in a scientific field

Advanced degree (PhD/ PharmD/ MS) preferred

Job description

Pliant Therapeutics, Inc. in South San Francisco, CA, seeks a dynamic Vice President of Regulatory Affairs & Quality (GxP) to lead global regulatory and quality oversight for an oncology portfolio.

This senior leader role partners with the COO and executive team to design scalable GxP infrastructure supporting early-phase trials and potential late-stage development. The role requires deep regulatory and quality expertise, a track record with INDs/CTAs, and strong agency engagement.