Head of Global Regulatory Advertising and Promotion

Role Overview

• Head of Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Policy
• Lead and direct post-marketing regulatory activities pertaining to marketing of Sobi products
• Responsible for regulatory review and approval of U.S. promotional, corporate, and medical communications
• Lead interactions with the FDA Office of Product Prescription and Drug Promotion
• Provide regulatory advice and guidance throughout the product life cycle
• Demonstrate leadership as the Regulatory Advertising and Promotion Leader
• Serve as strategic partner to internal leadership on regulatory risk assessment and mitigation
• Develop and leads departmental strategic initiatives

Requirements

• Minimum BS in Scientific discipline
• Advanced scientific degree (PhD, MD, PharmD, etc) or Juris Doctor preferred
• Minimum of 15 years of experience in pharmaceutical industry
• Minimum of 5 years as a regulatory Ad & Promo professional
• Experience in Rare Diseases, Hematology and/or Oncology a plus
• Expert knowledge of advertising promotion regulations and FDA Guidance documents
• Advanced experience with promotional and medical review supporting product communications
• Proficient in the use of AI digital tools

Benefits

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments