Associate Director, RA CMC

📋 Description

• The Associate Director Regulatory Affairs, CMC works with partners to deliver products to patients.
• Prepares CMC regulatory strategies to enable first pass approvals.
• Manages content strategy for regulatory submissions (INDs/CTAs, new marketing apps, variations).
• Represents CMC on cross-functional teams and with regulatory agencies.
• Leads initiatives within RA CMC and drives efficiencies across the program.

🎯 Requirements

• Bachelor’s in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field.
• 8 years pharma experience with at least 3 years leadership.
• 10 years pharma with 5+ years in RA or 5+ years in Discovery/R&D/Manufacturing (preferred).
• Experience with global regulatory strategies and Health Authority interactions.
• Strong oral/written communication; ability to work in a matrix environment.

🎁 Benefits

• Comprehensive benefits package (vacation, medical/dental/vision, 401(k)).
• Long-term incentive programs eligible.
• AbbVie equal opportunity employer; diverse and inclusive culture.