Vice President, Regulatory Affairs and Quality Assurance

About the position The Vice President, Regulatory Affairs & Quality Assurance will provide strategic and operational leadership across Regulatory and Quality functions in Janux’s growing biotech environment. This individual will be responsible for developing and executing regulatory and quality strategies that enable efficient advancement of the company’s pipeline from early development through commercialization, while ensuring sustained compliance with global regulatory and GxP requirements. Reporting to the Chief Medical Officer, the VP will be a key partner to clinical development, CMC, manufacturing, and commercial teams and will represent the company in interactions with global health authorities.

Responsibilities

• Develop, implement, and maintain global regulatory strategies across all stages of development, including IND/CTA preparation, clinical development, marketing applications (BLA), and post‑approval lifecycle management.
• Lead and oversee regulatory submissions and filings in the U.S. and internationally, ensuring high-quality, compliant, and timely deliverables.
• Serve as the primary regulatory advisor to executive leadership, providing risk‑based guidance aligned with corporate development goals
• Manage and lead interactions with global health authorities (FDA, EMA, etc.), including meetings, briefings, responses, and negotiations.
• Oversee regulatory intelligence activities, monitor evolving regulations and guidance to anticipate and mitigate regulatory risk.
• Establish and maintain a robust, scalable Quality Management System (QMS) covering GxP activities (GLP, GCP, GMP, GVP) across internal operations and external partners.
• Provide executive oversight of quality assurance functions, including audits, inspections, deviation management, CAPAs, and vendor qualification.
• Ensure inspection readiness and successfully lead regulatory inspections and partner audits.
• Promote a culture of quality, compliance, and continuous improvement across the organization.
• Build, mentor, and lead high‑performing Regulatory and Quality teams.
• Partner closely with Clinical Development, CMC, and Supply Chain to align regulatory and quality strategies with program timelines.
• Contribute to enterprise‑level planning, governance, and decision‑making as a member of the senior leadership team.

Requirements

• Bachelor’s degree required; advanced degree (MS, PhD, PharmD, or MD) in a life science discipline preferred.
• 15+ years (20 years preferred) of progressive experience in Regulatory Affairs and CMC/Quality within the biotechnology or pharmaceutical industry.
• Global Phase 1 through 4 regulatory experiences required.
• Demonstrated experience leading global regulatory strategies and successful major submissions (e.g., INDs, BLAs, NDAs, MAAs).
• Deep working knowledge of FDA, EMA, and ICH guidelines and regulatory frameworks, including GxP requirements.
• Proven ability to build and lead cross functional teams in a fast‑paced, evolving biotech environment
• Strong executive presence with the ability to influence internally and externally with health authorities and key stakeholders including KOLs, PIs and providers.

Benefits

• Annual bonus program
• Incentive stock option plan
• 401k plan with flat non-elective employer contribution
• Comprehensive medical insurance with 90-100% employer-paid premiums
• Dental and vision insurance
• HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
• Unlimited PTO
• Generous holiday schedule; includes summer and winter company shutdown
• Relocation assistance

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