Associate Director, RA CMC

📋 Description

• Lead regulatory RA CMC strategy development
• Prepare submissions for INDs/CTAs, variations, and renewals
• Coordinate with product development, RA, and manufacturing teams
• Interface with regulatory agencies (e.g., FDA) on CMC matters
• Manage change control and regulatory documentation lifecycle
• Mentor teams and drive RA CMC initiatives

🎯 Requirements

• Bachelor’s in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related
• 8 years pharma experience; 3+ years leadership
• 10 years pharma experience with 5+ in RA or 5+ in Discovery/R&D/Manufacturing
• Experience with global regulatory strategies and Health Authority interactions
• Strong communication skills; ability to operate in matrix environments

🎁 Benefits

• AbbVie-wide benefits package
• Long-term incentive programs eligibility
• Paid time off and health insurance