Senior Program Director – Commercial Regulatory Affairs (CORA)

Position Summary

The Senior Program Director is a senior-level regulatory affairs leader responsible for providing strategic and operational leadership for Commercial Regulatory Affairs (CORA). This position leads Program Review Committees (PRCs), develops regulatory strategies, partners with cross-functional business leaders, and serves as the primary regulatory decision-maker supporting pharmaceutical advertising, promotion, product launches, and FDA communications.

This role supports the U.S. Commercial Regulatory Affairs organization and works across therapeutic areas and product portfolios to ensure promotional materials and regulatory submissions comply with FDA regulations, healthcare compliance requirements, and company policies.

Position Overview

The Senior Program Director will:

• Lead Program Review Committees (PRCs) independently.
• Serve as the regulatory decision-maker for assigned therapeutic or business areas.
• Lead complex product launches and cross-functional regulatory initiatives.
• Provide strategic regulatory guidance for advertising and promotional materials.
• Represent the organization in official FDA communications.
• Support regulatory strategy development throughout the product lifecycle.
• Serve as a subject matter expert for Commercial Regulatory Affairs.

Key Responsibilities

Program Review Committee (PRC) Leadership

• Lead and chair Program Review Committees (PRCs).
• Serve as the primary regulatory decision-maker for assigned products and therapeutic areas.
• Partner with internal stakeholders and external advertising agencies throughout the promotional review process.
• Lead regulatory strategy for complex product launches and combination products.
• Monitor PRC activities and provide oversight for FDA communications, audits, compliance matters, and promotional review activities.
• Serve as Functional Leader for Commercial Regulatory Affairs with internal business partners.

Regulatory Strategy & FDA Communications

• Represent the organization during official FDA communications.
• Prepare, review, and approve FDA submissions, including Form FDA 2253.
• Develop regulatory strategies supporting promotional materials, product launches, and lifecycle management.
• Interpret FDA regulations and company policies to ensure compliant marketing and promotional activities.
• Develop and manage regulatory correspondence with the FDA.
• Review FDA comments and oversee follow-up responses and resubmissions.
• Maintain current knowledge of FDA guidance, enforcement trends, advisory opinions, and healthcare regulations.

Cross-Functional Leadership

• Collaborate with:
  • Commercial Marketing
  • Legal
  • Compliance
  • Medical Affairs
  • Clinical Development
  • Regulatory Affairs
  • Product Marketing
  • Cross-functional leadership teams
• Influence marketing strategy while ensuring regulatory compliance.
• Support Core Data Sheet (CDS) development and U.S. product labeling activities.
• Provide oversight and mentorship to junior regulatory staff.
• Represent Commercial Regulatory Affairs on enterprise-wide committees and strategic initiatives.

Regulatory Operations

• Review promotional concepts and draft marketing materials.
• Interpret FDA regulations and internal policies.
• Ensure promotional materials comply with healthcare regulations.
• Identify compliance risks and recommend appropriate solutions.
• Monitor industry trends and competitive intelligence.
• Support regulatory planning for assigned products and therapeutic areas.
• Lead departmental initiatives, process improvements, organizational projects, and strategic planning efforts.

Required Qualifications

• Bachelor's degree in:
  • Life Sciences
  • Law
  • Public Policy
  • Marketing
  • Business
  • Education
  • Related discipline
• Graduate degree strongly preferred, including:
  • JD
  • MBA
  • MS
  • PharmD
  • PhD
  • Related advanced degree
• Minimum 7 years of experience in:
  • Regulatory Affairs
  • Legal
  • Healthcare Compliance
  • Regulatory Policy
  • Auditing
  • Communications
  • Bio/Pharmaceutical industry
• Experience leading cross-functional teams and enterprise initiatives.
• Strong knowledge of FDA regulations governing pharmaceutical advertising and promotion.
• In-depth understanding of:
  • Healthcare compliance
  • Product marketing
  • Clinical affairs
  • Regulatory strategy
  • Pharmaceutical commercialization

Preferred Qualifications

• Regulatory Advertising and Promotion experience.
• Experience leading Program Review Committees (PRCs).
• Experience supporting FDA promotional submissions and FDA Form 2253.
• Experience leading complex pharmaceutical product launches.
• Knowledge of:
  • Anti-Kickback Statute
  • Government Fraud & Abuse regulations
  • Off-Label Promotion
  • PhRMA Code
  • FDA promotional regulations
• Experience supporting commercial regulatory strategy across multiple therapeutic areas.

Core Competencies

• Strategic Agility
• Executive Decision Making
• Regulatory Leadership
• Cross-Functional Collaboration
• Regulatory Risk Management
• Influencing Without Authority
• Executive Communication
• Negotiation & Stakeholder Management
• Organizational Leadership
• Project & Program Management
• Continuous Improvement
• Innovation & Change Management

Technical & Business Skills

• Pharmaceutical Regulatory Affairs
• Commercial Regulatory Strategy
• FDA Promotional Review
• Healthcare Compliance
• Product Launch Strategy
• Regulatory Communications
• Risk Assessment
• Marketing Material Review
• Cross-Functional Leadership
• Regulatory Intelligence
• Policy Interpretation
• Organizational Effectiveness
• Capacity Planning
• Budget Planning
• Strategic Planning