Manager, RA CMC

📋 Description

• Prepares CMC regulatory product strategies with limited supervision.
• Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals
• Analyses and interprets information that impacts regulatory decisions; seeks expert advice as
• Reviews regulatory submission documentation to present data to regulatory agencies.
• Responds to global regulatory information requests under limited supervision.
• Develops strategies for CMC-related agency interactions; manages agency meeting packages under

🎯 Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• 6 years biopharmaceutical or related industry experience; 6 years RA/R&D/Operations preferred
• Experience in complex, matrix environments; strong oral and written communication skills.

🎁 Benefits

• AbbVie offers a comprehensive benefits package including PTO, medical/dental/vision insurance, and
• Eligible to participate in long-term incentive programs.
• Company-wide commitment to equal opportunity and inclusive culture.