Senior Associate Regulatory Affairs Submission Management - Hybrid

Role: Senior Associate, Regulatory Affairs Submission Management, overseeing medium to high impact regulatory submission projects within biopharma. Responsibilities include managing submission timelines, coordinating with cross-functional teams, ensuring quality and compliance of dossiers, and liaising with publishing vendors. Experience in regulatory submissions, content planning, and quality review is critical. Requirements: Bachelor's degree; 4+ years in pharmaceutical or related industries, with experience in publishing software tools like Documentum or eCTDXPress. Preferred: PMP and RAC certifications, experience in Regulatory Affairs or Regulatory Operations, leadership skills. High-Value: Experience with regulatory submissions in biologics or pharmaceuticals, familiarity with GxP standards, and multi-project coordination. Work setup: Hybrid in North Chicago, IL, with some supervision responsibilities and mentoring duties.