Senior Program Director, Commercial Regulatory Affairs

Job Title: Senior Program Director - Commercial Regulatory Affairs (Advertising & Promotion) Employment Type: Contract on W2 Workplace Type: Onsite Duration: 12+ Months (Potential Extension) Job Description We are seeking an experienced Senior Program Director - Commercial Regulatory Affairs (Advertising & Promotion) to support one of our leading biotechnology clients. This position will provide strategic regulatory leadership for commercial promotional materials and serve as the regulatory lead across cross-functional review committees. The ideal candidate will have extensive experience reviewing promotional materials, partnering with Medical, Legal, Marketing, and Compliance teams, and ensuring compliance with FDA promotional regulations. Key Responsibilities Lead and chair cross-functional Program Review Committees (PRCs) Provide regulatory guidance for promotional and advertising materials Review HCP and patient-facing promotional content Partner with Medical, Legal, Marketing, Compliance, and Commercial teams Ensure promotional materials comply with FDA regulations and company policies Lead regulatory strategy for commercial product launches Prepare and manage FDA promotional submissions, including Form FDA 2253 Support product labeling and Core Data Sheet activities Interpret FDA guidance and regulatory changes Review promotional claims, fair balance, and product messaging Mentor junior regulatory professionals and support departmental initiatives Basic Qualifications Bachelor's degree required Advanced degree preferred (PharmD, PhD, MS, MBA, JD) 7+ years of Regulatory Affairs, Commercial Regulatory, Advertising & Promotion, Compliance, or Medical/Legal/Regulatory experience within the pharmaceutical or biotechnology industry Strong FDA promotional compliance knowledge Experience supporting commercial product launches Excellent communication and stakeholder management skills #J-18808-Ljbffr Pharmaceutical Company