Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC) - Hybrid

📋 Description

• Manage, compile, and author CMC sections of marketed product variations with minimal management
• Update simple CMC documents independently
• Partner with RA CMC Project Leads to create content plans, bundling strategies, and project
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and
• Independently run team reviews and management reviews of submission documents

🎯 Requirements

• BA/BS in Chemical, and/or Biological Sciences/relevant discipline
• 4 years pharmaceutical or industry related experience; 1-2 years in quality systems or cross
• 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in
• Strong working knowledge of CTD structure or manufacturing unit operations
• Superior oral and written communication skills
• Experience working with electronic document management systems

🎁 Benefits

• AbbVie offers comprehensive benefits including paid time off, medical/dental/vision insurance and
• This job is eligible to participate in our short-term incentive programs