Remote Global Regulatory Lead: Cardiovascular

Apex Systems; Overland Park (KS); Remote; USD 160,000 - 210,000; Full time

Benefits offered by this job

Health insurance

401K

ESPP

HSA

Career coaching

Training programs

Discounts

Education resources

Job summary

Everforth Apex Systems is recruiting a Global Regulatory Lead to provide strategic regulatory leadership for a late‑stage cardiovascular development program, driving global strategies and NDA activities across multiple regions.

The role requires leading cross‑functional teams, coordinating regulatory submissions, and engaging with health authorities to ensure timely product registration and risk mitigation across partner organizations.

Qualifications

• PhD/MD/PharmD/MS/BS in a relevant scientific discipline.
• 4+ years in Regulatory Affairs with cardiovascular drug development.
• Global regulatory experience across EU, JP, AU and other regions.

Responsibilities

• Lead global regulatory strategies for a late-stage cardiovascular program.
• Coordinate NDA preparation, submission, and review activities.
• Drive regulatory readiness and risk mitigation across teams.
• Engage health authorities and lead agency interactions globally.
• Collaborate with clinical, nonclinical, and biostatistics teams.
• Provide SME input on protocols, reports, and labeling strategies.

Skills

Global Regulatory Lead

Regulatory strategy

NDA submissions

Cross-functional leadership

Multi-region regulatory

Education

PhD/MD/PharmD/MS/BS in relevant field

Job description

Everforth Apex Systems is recruiting a Global Regulatory Lead to provide strategic regulatory leadership for a late‑stage cardiovascular development program, driving global strategies and NDA activities across multiple regions.

The role requires leading cross‑functional teams, coordinating regulatory submissions, and engaging with health authorities to ensure timely product registration and risk mitigation across partner organizations.