Global Regulatory Lead: Cardiovascular NDA Strategy

The Panther Group; Overland Park (KS); On-site; USD 107,000 - 179,000; Full time

Job summary

The Panther Group is seeking a Global Regulatory Affairs Lead in Overland Park, KS. This full-time role requires guiding global and U.S. regulatory strategy through milestones such as NDA preparation and submission, with strong cross-functional leadership across partner organizations.

A PhD/MD/PharmD/MS/BS in a relevant field and extensive regulatory affairs experience, especially in cardiovascular drug development, are required. Excellent communication and independence are essential.

Qualifications

• PhD/MD/PharmD/MS/BS in a relevant science field.
• Significant pharma regulatory affairs experience.
• Cardiovascular drug development experience.
• Experience as Global or U.S. Regulatory Lead.
• Strong regulatory knowledge and leadership.

Responsibilities

• Lead global and U.S. regulatory strategy for a late-stage cardiovascular development program.
• Align regulatory plans with clinical development objectives and business priorities.
• Provide regulatory leadership through database lock, NDA preparation, submission, and review.
• Lead cross-functional Global Regulatory Teams and coordinate activities across partner organizations.
• Direct integrated submission planning, regulatory readiness, risk management, and execution.
• Develop product-registration strategies and translate them into actionable plans.
• Identify alternative regulatory pathways and develop risk-mitigation strategies.
• Develop and execute global and U.S. Health Authority engagement plans.
• Lead or support regulatory agency meetings, communications, briefing documents, and responses.
• Advise cross-functional teams on regulatory requirements, risks, and submission approaches.
• Resolve complex regulatory issues by engaging scientific, technical, and regulatory experts.
• Communicate regulatory strategy, recommendations, and risks to senior leadership.
• Provide regulatory input into protocols, study reports, and submission documents.
• Contribute to product profiles, core data sheets, and labeling strategies.

Skills

Regulatory leadership

Strategic thinking

Stakeholder management

Cross-functional leadership

Regulatory affairs knowledge

Communication skills

Education

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

Job description

The Panther Group is seeking a Global Regulatory Affairs Lead in Overland Park, KS. This full-time role requires guiding global and U.S. regulatory strategy through milestones such as NDA preparation and submission, with strong cross-functional leadership across partner organizations.

A PhD/MD/PharmD/MS/BS in a relevant field and extensive regulatory affairs experience, especially in cardiovascular drug development, are required. Excellent communication and independence are essential.