Associate Director, RA CMC

📋 Description

• Prepares CMC regulatory product strategies and submissions (new apps, amendments, renewals
• Analyzes regulatory information and seeks expert support for strategies and submissions.
• Reviews and revises submissions to present data and strategy to agencies.
• Leads agency meetings planning and pre-meeting submissions; serves as RA CMC point of contact.
• Manages change control and manufacturing change requests with regulatory understanding.
• Represents CMC RA on cross-functional teams to drive efficiency and first-pass approvals.

🎯 Requirements

• Bachelor’s in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field; advanced
• 8 years pharma experience with at least 3 years leadership.
• 10 years pharma experience with 5+ years in RA or 5+ years in Discovery/R&D/Manufacturing
• Experience developing global regulatory strategies and working with Health Authorities.
• Experience in complex, matrix environments; strong communication skills.
• Note: Higher education may compensate for years of experience.

🎁 Benefits

• AbbVie offers comprehensive benefits including PTO, medical/dental/vision insurance, and 401(k).
• Eligible for long-term incentive programs; compensation determined by location and role.
• AbbVie is an equal opportunity employer; commitment to integrity and innovation.