Associate Director, RA CMC

📋 Description

• Lead CMC regulatory strategy development for first pass approvals
• Prepare/manages regulatory submissions (INDs/CTAs, amendments)
• Collaborate with product development, RA, and Operations on strategy
• Represent CMC to Health Authorities and internal teams
• Drive regulatory change control and project alignment across functions
• Mentor teammates and lead internal RA CMC initiatives

🎯 Requirements

• Bachelor’s in Pharmacy, Chemistry, Biology or related field
• 8 years pharma experience with 3+ years in leadership
• 10 years pharma with 5+ in regulatory affairs or 5+ in Discovery/R&D/Manufacturing
• Experience with global regulatory strategies and Health Authority interactions
• Strong oral and written communication
• Ability to navigate complex, matrix environments

🎁 Benefits

• AbbVie benefits package including PTO and healthcare
• Long-term incentive programs eligibility