Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC) - Hybrid
AbbVie84500 - 162000
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Job Description
📋 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