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

📋 Description

• Manage, compile, and author CMC sections for marketed product variations with limited oversight
• Update simple CMC documents independently
• Collaborate with RA CMC Project Leads to create content plans and timelines
• Coordinate with cross-functional teams to ensure file-ability and acceptance of CMC sections
• Oversee projects to ensure thoroughness, accuracy, and timely CMC dossiers and responses
• Support submission document templates and regulatory systems; communicate issues to management

🎯 Requirements

• BA/BS in Chemical and/or Biological Sciences or related field
• 4 years pharmaceutical or industry experience; 1-2 years in quality systems or cross-functional
• 5 years pharma experience with 1-2 years in regulatory affairs or 1-2 years in
• Strong knowledge of manufacturing unit operations or CTD structure
• Excellent oral and written communication; ability to work with global teams
• Experience with electronic document management systems; ability to manage multiple projects under

🎁 Benefits

• Comprehensive benefits package including PTO, medical/dental/vision, and 401(k) for eligible
• Eligible to participate in short-term incentive programs