Global Regulatory Affairs Lead

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

Global Regulatory Affairs Lead

Location: Overland Park, Kansas

Schedule: Full-time, 40 hours per week

Pay: Up to $130 per hour, depending on experience

We are seeking an accomplished Global Regulatory Affairs Lead to provide strategic regulatory leadership for a late-stage cardiovascular drug-development program. This individual will serve as the Global Regulatory Lead and/or U.S. Regulatory Lead, guiding global and U.S. regulatory strategy through critical milestones that include database lock, NDA preparation, submission, and regulatory review. This highly visible position requires an experienced pharmaceutical regulatory professional who can lead complex global workstreams, advise senior stakeholders, collaborate across partner organizations, and translate scientific and regulatory considerations into executable development and registration strategies.

What You’ll Do

• Lead global and U.S. regulatory strategy for a late-stage cardiovascular development program.
• Align regulatory plans with clinical-development objectives and broader 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 the appropriate scientific, technical, and regulatory experts.
• Communicate regulatory strategy, recommendations, and risks to senior leadership.
• Provide regulatory input into clinical protocols, study reports, statistical plans, clinical summaries, and submission documents.
• Contribute to product profiles, core data sheets, and U.S. and global labeling strategies.

Required Qualifications

• PhD, MD, PharmD, MS, or BS in a relevant scientific discipline.
• Significant professional experience in pharmaceutical Regulatory Affairs.
• Previous cardiovascular drug-development experience.
• Prior experience serving as a Global Regulatory Lead and/or U.S. Regulatory Lead.
• Experience supporting late-stage clinical development and major regulatory submissions.
• Strong knowledge of global and U.S. pharmaceutical regulations.
• Demonstrated ability to lead complex programs across multiple functions and geographic regions.
• Excellent communication, leadership, influencing, and relationship-building skills.
• Ability to work independently, exercise sound judgment, and manage competing priorities.

Preferred Qualifications

• Direct experience leading an original NDA submission.
• Proven success developing and implementing global regulatory strategies.
• Experience establishing Health Authority engagement strategies and leading agency interactions.
• Demonstrated success negotiating regulatory objectives with Health Authorities.
• Experience working within a joint-development or strategic-partnership environment.
• Knowledge of global labeling strategy, Target Product Profiles, and Company Core Data Sheets.
• Experience communicating regulatory recommendations and risks to senior leadership.
• Ability to translate complex scientific and regulatory issues into clear business recommendations.

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