Senior Program Director, Commercial Regulatory Affairs

Key Responsibilities

• Lead and chair Program Review Committees (PRCs) for assigned therapeutic or portfolio areas
• Serve as decision-maker for regulatory review and approval of advertising and promotional materials
• Lead complex product launches, combination products, and cross-functional regulatory initiatives
• Develop and execute regulatory strategies for marketing, advertising, and FDA communications submissions
• Represent the organization in FDA interactions, including correspondence and 2253 submissions
• Interpret FDA regulations, guidance, enforcement trends, and communicate impacts internally
• Provide regulatory input on promotional concepts and materials
• Support U.S. labeling strategy and Core Data Sheet (CDS) development
• Collaborate with commercial, legal, clinical, and regulatory stakeholders
• Oversee and guide junior regulatory staff and cross-functional teams
• Lead process improvement initiatives to enhance regulatory efficiency and compliance
• Lead without direct authority and influence senior stakeholders
• Manage complex, cross-functional regulatory processes
• Think strategically with strong business acumen
• Have high ethical standards and compliance mindset
• Interpret and communicate complex regulatory guidance clearly

Qualifications

• Education: Bachelor’s degree required (life sciences, law, business, public policy, or related field); advanced degree preferred (JD, MBA, MS, PharmD, PhD, or equivalent)
• Experience: 7+ years in regulatory, legal, compliance, policy, or related pharmaceutical industry roles; strong experience in regulatory advertising and promotion preferred; 4+ years leading cross-functional programs or large-scale initiatives preferred
• Skills & Competencies: Strong regulatory judgment and decision-making ability; excellent written and verbal communication skills; strong project management and organizational skills; strategic thinking with strong business acumen; high ethical standards and compliance mindset; ability to interpret and communicate complex regulatory guidance clearly