The Director Regulatory Affairs for Chemistry, Manufacturing and Controls Post Approval Change Dossier Management (CMC PAC DM) combines scientific, regulatory and business knowledge with superior leadership skills to lead the PAC DM team responsible for ensuring RA-CMC post approval change objectives are met.  Builds and maintains partnerships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Provides an environment for staff members to develop their careers and take their own leadership positions throughout AbbVie.

Responsibilities

• Leads a global RA CMC PAC DM team who project manages marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.
• Devises (or advises their team on) tactical strategies for executing post approval changes with complicated scenarios (e.g., complex dosage form or multiple operational changes, aggressive timelines).
• Provides leadership to PAC-DM staff to ensure consistency in the execution of post approval changes across all global programs. 
• Provides direction and guidance to direct reports and their teams, as applicable, who exercise significant latitude and independence in their assignments.
• Designs initiatives to drive business efficiencies across the organization (within or outside of the regulatory groups). Identifies opportunities for process improvements, identifies/solicits solutions and drives for implementation. Ensures enterprise culture initiatives are implemented across the PAC-DM team. 
• Effectively mentors staff to achieve business objectives and staff member personal growth. Reviews and provides feedback on RA training programs.
• Provides leadership to PAC-DM staff by communicating and providing guidance towards achieving department objectives. Identifies engagement needs and partners with stakeholders to implement action plans accordingly. 
• Trains, develops and mentors individuals; includes formal supervisory responsibilities. Evaluates performance of and assists in career development planning for PAC-DM staff.