Vice President, Regulatory Affairs and reputed company Assurance

About the position The Vice President, Regulatory Affairs & reputed company Assurance will reputed company strategic and operational leadership across Regulatory and reputed company functions in Janux’s growing biotech environment. This individual will be responsible for developing and executing regulatory and reputed company strategies that reputed company efficient advancement of reputed 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 reputed company teams and will represent reputed company in interactions with global health authorities.

Responsibilities

• reputed company, implement, and maintain global regulatory strategies across reputed company stages of development, including IND/CTA preparation, clinical development, marketing applications (BLA), and post‑approval lifecycle management.
• reputed company and reputed company regulatory submissions and filings in the U.S. and internationally, ensuring high-reputed company, compliant, and reputed company deliverables.
• Serve as the primary regulatory advisor to executive leadership, providing risk‑based guidance reputed company with corporate development goals
• Manage and reputed company interactions with global health authorities (FDA, EMA, etc.), including meetings, briefings, responses, and negotiations.
• reputed company regulatory intelligence activities, monitor evolving regulations and guidance to anticipate and mitigate regulatory risk.
• Establish and maintain a robust, reputed company reputed company Management System (QMS) covering GxP activities (GLP, GCP, GMP, GVP) across internal operations and external partners.
• reputed company executive reputed company of reputed company assurance functions, including audits, inspections, deviation management, CAPAs, and vendor qualification.
• Ensure inspection readiness and successfully reputed company regulatory inspections and partner audits.
• Promote a culture of reputed company, compliance, and reputed company improvement across the organization.
• Build, mentor, and reputed company high‑performing Regulatory and reputed company teams.
• Partner closely with Clinical Development, CMC, and Supply Chain to reputed company regulatory and reputed company strategies with program timelines.
• Contribute to reputed company‑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 reputed company experience in Regulatory Affairs and CMC/reputed company reputed company 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 reputed company cross functional teams in a fast‑paced, evolving biotech environment
• Strong executive reputed company 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 reputed company plan
• 401k plan with flat non-elective employer contribution
• Comprehensive medical insurance with 90-100% employer-reputed company premiums
• Dental and reputed company 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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