The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) Post Approval Change (PAC) 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.  This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings. 

Responsibilities:

• Independently manage, compile, and author CMC sections of marketed product variations. 
• Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines as needed.  
• 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.  Drive team and management reviews with minimal intervention by project lead.  Provide coaching to more junior RA CMC colleagues during team and management reviews.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects and for projects being managed by coached/mentored employees.
• Independently provide tactical support to integrate technical issues with regulatory requirements and emerging standards. 
• Develop and utilize current best practices for use of regulatory business systems within the group.
• Identification of systems issues and communication to management/key system SMEs.
• Identify and communicate content gaps and risks for variation documents. 
• Coach, mentor, and develop junior staff. 
• Provide guidance on use of submission document templates. 
• Support annual reports and renewals (ad hoc baseline support)
• This position will work a hybrid work schedule from our Lake County, IL AbbVie headquarters.

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