Global Regulatory Lead – Cardiovascular NDA Strategy

Planet Pharma; Overland Park (KS); On-site; USD 164,000 - 178,000; Full time

Job summary

Planet Pharma seeks a Global Regulatory Lead (GRL) / US Regulatory Lead (USRL) to provide strategic regulatory leadership for a late‑stage cardiovascular development program, serving as the primary regulatory lead for Milvexian. The role drives global regulatory strategy, health authority engagement, and cross‑functional collaboration across partner organizations.

The candidate will guide NDA readiness, submissions, and review activities, oversee global submission workstreams, and ensure

Qualifications

• Solid scientific background with PhD, MD, PharmD, MS or BS in a relevant discipline.
• Regulatory Affairs experience (4–7+ years) in cardiovascular drug development.

Responsibilities

• Serve as Global Regulatory Lead (GRL) and/or US Regulatory Lead (USRL) for a late-stage cardiovascular development program.
• Lead global regulatory strategy for the Milvexian indication and align with program objectives and business goals.
• Provide regulatory leadership through key milestones including DBL, NDA preparation, submission and review activities.
• Lead internal and joint Global Regulatory Teams (GRTs) to drive collaboration and execution across partner organizations.
• Drive preparation and regulatory readiness for the original NDA submission in progress.
• Provide global submission leadership with integrated submission planning, cross-functional alignment, risk identification and high-quality execution across global workstreams.
• Develop product registration strategies and translate them into actionable operational plans.
• Create alternative regulatory pathways and risk mitigation strategies to achieve program objectives.
• Formulate U.S. regulatory strategies and oversee submission activities.

Skills

Regulatory leadership

Cardiovascular drugs

GxP regulatory strategy

Education

PhD/MD/PharmD/MS/BS in a relevant scientific discipline

Job description

Planet Pharma seeks a Global Regulatory Lead (GRL) / US Regulatory Lead (USRL) to provide strategic regulatory leadership for a late‑stage cardiovascular development program, serving as the primary regulatory lead for Milvexian. The role drives global regulatory strategy, health authority engagement, and cross‑functional collaboration across partner organizations.

The candidate will guide NDA readiness, submissions, and review activities, oversee global submission workstreams, and ensure