The Senior Associate, RA CMC is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.  The Senior Associate will also ensure proper communication with all key partners in the functional departments in support of regulatory filings. 

Responsibilities

• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.  Update simple CMC documents independently.
• Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines.  
• 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 responses. Independently run team review and management reviews of submission documents.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.  
• Provide input into and utilize current best practices for use of regulatory business systems within the group.
• Timely communication of systems issues to management.
• Communicate content gaps and risks for variation documents identified by RA CMC Project Leads. 
• Provide guidance on use of submission document templates. 
• Support annual reports and renewals (ad hoc baseline support)
• This role works a hybrid work schedule (3 days in office & 2 days remotely) from the Lake County, IL; Waltham, MA or Irvine, CA AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required