Reg Affairs Director

📋 Description

• Lead regulatory advertising & promotion for assigned products.
• Guide promotional strategy, claims, and risk positioning.
• Align messaging with labeling and data with cross-functional teams.
• Apply FDA regulations, OPDP guidance, and enforcement trends.
• Assess regulatory risk and propose practical mitigation strategies.
• Lead disease awareness, digital content, and launch campaigns.

🎯 Requirements

• Advanced scientific degree (PharmD, PhD, MD) or equivalent.
• 8+ years pharma exp with 5+ years ad promo exp.
• Deep understanding of FDA promotional regs, OPDP guidance.
• Experience supporting commercial launches and/or late-stage programs.
• Demonstrated ability to influence cross-functional stakeholders.

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• Comprehensive medical, dental, and vision for you and dependents
• Flexible PTO and company-paid holidays
• Hybrid work model with flexibility
• Career development via LinkedIn Learning, LifeLabs, BetterUp