Reg Affairs Assoc. Director

📋 Description

• Lead regulatory oversight of promotional materials for assigned products.
• Ensure FDA regulations, OPDP guidance, and policy compliance.
• Shape messaging strategy; anticipate regulatory risk and opportunities.
• Partner with Commercial, Medical, Legal, and Clinical to align messaging with labeling.
• Lead MLR review of promotional materials; ensure accuracy and balance.
• Develop core claims documents and messaging frameworks.

🎯 Requirements

• Advanced degree (PharmD, PhD, MD) or equivalent.
• 8+ years pharma; 5+ years ad promo experience.
• Deep knowledge of FDA promo regulations and OPDP guidance.
• Experience supporting commercial launches and/or late-stage programs.
• Proven ability to influence cross-functional stakeholders in a matrixed environment.
• Preferred: rare disease or specialty therapeutics experience.

🎁 Benefits

• 100% employer-paid health, dental, and vision for you and dependents.
• Hybrid work model with flexibility.
• Unlimited flexible PTO and paid parental leave.
• Flexible spending accounts and company-provided life/disability insurance.
• 401K with employer match and Employee Stock Purchase Program.
• Subsidized lunch on in-office days.