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 and timelines.
• Collaborate with 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

• Bachelor's degree in Chemical and/or Biological Sciences or relevant discipline
• 4 years pharma or industry experience; 1-2 years in quality systems or cross-functional PM
• 5 years pharma experience including regulatory affairs or Discovery/R&D/Manufacturing
• Strong knowledge of manufacturing unit operations or CTD structure
• Excellent oral and written communication; able to collaborate globally
• Experience with electronic document management systems

🎁 Benefits

• AbbVie comprehensive benefits package including PTO, medical/dental/vision, and 401(k)
• Eligible to participate in short-term incentive programs
• Competitive compensation with potential for adjustment based on location and performance