Head of Global Regulatory, Advertising and Promotion

Role Overview

• Report to the Head of Global Regulatory Policy, Intelligence and Advertising & Promotion
• 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
• Interaction with the FDA Office of Product Prescription and Drug Promotion
• Provide regulatory advice and guidance on Advertising and Promotion for global promotional and non-promotional materials
• Serve as an internal subject matter expert on FDA Advertising & Promotion issues
• Foster a healthy business partnership environment with cross-functional stakeholders

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 knowledge of promotional and medical review supporting product communications

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