Head of Global Regulatory Advertising and Promotion

📋 Description

• Lead post-marketing regulatory activities for marketing of Sobi products.
• Own the Global Material review process and regulatory reviews of promotional materials.
• Interact with FDA OPDP/APLB; escalate and review to ensure compliant, timely execution.
• Collaborate cross-functionally to provide regulatory guidance across product life cycle.

🎯 Requirements

• BS in scientific field; advanced degree preferred (PhD/MD/PharmD or JD).
• 15+ years in pharma; 5+ years in regulatory Ad & Promo; experience with Rare Diseases
• Deep knowledge of FDA promo regulations and guidance; experience with OPDP and APLB.
• Strong regulatory strategy, risk assessment, and communication skills; ability to lead
• Willingness to travel occasionally; proficient use of AI digital tools.

🎁 Benefits

• Competitive compensation and comprehensive benefits package.
• Generous time off, conference opportunities, and work-life balance focus.
• Bonuses (short-term and long-term) as part of total rewards.