Remote Senior Principal, Regulatory Strategy Leader

Lumanity; United States; Remote; USD 180,000 - 280,000; Full time

Benefits offered by this job

Competitive salary + bonus

Medical, dental, vision

401(k) with employer match

Flexible PTO

Health savings account options

Employee Assistance Program

Job summary

Lumanity is seeking a Senior Principal, Regulatory Strategy to deliver high-impact regulatory strategies for biopharma clients. You will partner with senior leadership to shape development programs, provide expert regulatory guidance, and drive growth across the Clinical & Regulatory practice.

You will lead strategic advisory engagements, mentor junior consultants, and represent Lumanity at industry forums, influencing regulatory thinking and service evolution.

Qualifications

• Minimum 15+ years progressive regulatory experience in consulting and in-house biopharma regulatory roles.
• Direct experience leading regulatory strategies for development programs across multiple stages and therapeutic areas.
• Experience collaborating with C-suite executives and function heads on regulatory strategy.

Responsibilities

• Provide strategic regulatory advisory and client partnership with senior executives.
• Lead regulatory strategy across diverse programs, including novel modalities.
• Drive business development and mentorship within the regulatory practice.
• Oversee delivery quality, risk management, and project profitability.
• Represent the firm in industry forums and regulatory events.

Skills

Regulatory strategy

Executive advisory

Biopharma

Business development

Global regulation

Pre-IND meetings

Cross-functional leadership

Therapeutic modalities

Education

PhD or MPH

Job description

Lumanity is seeking a Senior Principal, Regulatory Strategy to deliver high-impact regulatory strategies for biopharma clients. You will partner with senior leadership to shape development programs, provide expert regulatory guidance, and drive growth across the Clinical & Regulatory practice.

You will lead strategic advisory engagements, mentor junior consultants, and represent Lumanity at industry forums, influencing regulatory thinking and service evolution.