Associate Director, RA CMC

📋 Description

• Prepares CMC regulatory product strategies for submissions
• Manages regulatory submissions including new apps and amendments
• Reviews data to present to regulatory agencies
• Prepares for agency meetings and manages pre-meeting content
• Oversees change control with regulatory/compliance context
• Collaborates across RA CMC, product dev, and operations for approvals

🎯 Requirements

• Bachelor’s in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related
• 8 years pharma exp with 3+ years leadership
• 10 years pharma exp incl. 5+ in regulatory or 5+ in R&D/Manufacturing
• Experience in global regulatory strategies and Health Authority
• Strong oral/written communication; matrix environment
• Higher education can offset years of experience

🎁 Benefits

• AbbVie is an equal opportunity employer
• Comprehensive benefits package and long-term incentive programs
• Pay/disclosure information as per local laws where applicable